| Device Type ID | 2552 |
| Device Name | Needle, Hypodermic, Single Lumen |
| Regulation Description | Hypodermic Single Lumen Needle. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5570 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FMI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2552 |
| Device | Needle, Hypodermic, Single Lumen |
| Product Code | FMI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hypodermic Single Lumen Needle. |
| CFR Regulation Number | 880.5570 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
B. BRAUN MEDICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
B. BRAUN MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
B. BRAUN MELSUNGEN AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BD | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
BECTON, DICKINSON & CO. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
BECTON, DICKINSON AND COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIABETIC SUPPLY OF SUNCOAST, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EXELINT INTERNATIONAL CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FACET TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FACET TECHNOLOGIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
GEMTIER MEDICAL (SHANGHAI) INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GREINER BIO-ONE NA INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HTL-STREFA S.A. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
JIAMEI-UN CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KOFU FACTORY OF TERUMO CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDEXEL CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MYCO MEDICAL SUPPLIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NORFOLK MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NOVO NORDISK INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
OCUJECT, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OWEN MUMFORD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
RETRACTABLE TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHANGHAI CARELIFE INTERNATIONAL TRADING CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHINA MED CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SOL-MILLENNIUM MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STERILANCE MEDICAL (SUZHOU) INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TELEFLEX MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERUMO (PHILIPPINES) CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERUMO CARDIOVASCULAR SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
TERUMO CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERUMO EUROPE N.V. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
VIDACARE CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VIDACARE LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WAISMED LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
WENZHOU BEIPU SCIENCE & TECHNOLOGY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WENZHOU WUZHOU IMPORT & EXPORT CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
YIDOBIO INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
YPSOMED AG | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Needle | 527 |
Detachment Of Device Component | 312 |
Leak / Splash | 262 |
Break | 253 |
Failure To Deliver | 191 |
Power Problem | 187 |
Detachment Of Device Or Device Component | 119 |
Infusion Or Flow Problem | 114 |
Device Operational Issue | 93 |
Difficult Or Delayed Activation | 81 |
Device Contamination With Chemical Or Other Material | 81 |
Obstruction Of Flow | 79 |
Protective Measures Problem | 76 |
Complete Blockage | 73 |
Material Twisted / Bent | 70 |
Device Contaminated During Manufacture Or Shipping | 66 |
Device Operates Differently Than Expected | 63 |
Occlusion Within Device | 56 |
Product Quality Problem | 55 |
Crack | 55 |
Loose Or Intermittent Connection | 52 |
Appropriate Term/Code Not Available | 48 |
Dull, Blunt | 45 |
Bent | 42 |
Fluid Leak | 41 |
Hub | 40 |
Adverse Event Without Identified Device Or Use Problem | 38 |
Use Of Device Problem | 37 |
Difficult To Remove | 37 |
Device Stops Intermittently | 36 |
Safety Interlock | 35 |
Physical Property Issue | 34 |
Device Markings / Labelling Problem | 33 |
Device Damaged Prior To Use | 29 |
Material Separation | 27 |
Syringe | 27 |
Fracture | 25 |
Separation Failure | 25 |
Mechanical Problem | 24 |
Packaging Problem | 24 |
Delivered As Unsterile Product | 23 |
Manufacturing, Packaging Or Shipping Problem | 22 |
Positioning Failure | 21 |
Failure To Adhere Or Bond | 19 |
Insufficient Information | 18 |
Fail-Safe Design Failure | 17 |
Connection Problem | 17 |
Fail-Safe Problem | 17 |
Material Integrity Problem | 15 |
Material Deformation | 15 |
Material Fragmentation | 15 |
Volume Accuracy Problem | 14 |
Cannula | 14 |
Difficult To Insert | 13 |
Device Handling Problem | 12 |
Battery Problem | 11 |
Luer Valve | 10 |
Cap | 9 |
Material Protrusion / Extrusion | 9 |
Needle, Separation | 7 |
Disconnection | 7 |
Corroded | 7 |
Fail-Safe Did Not Operate | 7 |
Device Difficult To Setup Or Prepare | 7 |
No Flow | 7 |
Difficult To Open Or Close | 7 |
Activation Problem | 6 |
None | 6 |
Improper Or Incorrect Procedure Or Method | 6 |
Insufficient Flow Or Under Infusion | 6 |
Defective Device | 6 |
Loss Of Power | 6 |
Unsealed Device Packaging | 5 |
Device Issue | 5 |
Device Or Device Fragments Location Unknown | 5 |
Adapter (Adaptor) | 5 |
Device Slipped | 5 |
Holder | 5 |
Patient-Device Incompatibility | 5 |
Device Component Or Accessory | 5 |
Difficult Or Delayed Positioning | 5 |
Device Dislodged Or Dislocated | 5 |
Component Missing | 5 |
Retraction Problem | 5 |
Failure To Cut | 5 |
Shielding Failure | 4 |
Activation, Positioning Or Separation Problem | 4 |
Human-Device Interface Problem | 4 |
Contamination During Use | 4 |
Tear, Rip Or Hole In Device Packaging | 4 |
Difficult To Open Or Remove Packaging Material | 4 |
Split | 4 |
Failure To Disconnect | 4 |
Entrapment Of Device | 4 |
Mechanical Jam | 4 |
Sticking | 4 |
Partial Blockage | 3 |
Physical Resistance / Sticking | 3 |
Tube | 3 |
Short Fill | 3 |
| Total Device Problems | 4009 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Arrow International Inc | II | May-30-2018 |
| 2 | Arrow International Inc | II | Feb-13-2018 |
| 3 | B. Braun Medical, Inc. | II | Feb-09-2018 |
| 4 | Becton Dickinson & Company | II | Oct-11-2018 |
| 5 | Becton Dickinson & Company | II | Dec-07-2017 |
| 6 | Becton Dickinson & Company | II | Sep-11-2017 |
| 7 | Becton Dickinson & Company | II | Jul-19-2017 |
| 8 | Centurion Medical Products Corporation | II | Jan-04-2018 |
| 9 | Global Healthcare Inc | II | Sep-22-2016 |
| 10 | Guangzhou Improve Medical Instruments Co., Ltd. | II | Aug-12-2018 |
| 11 | Guangzhou Improve Medical Instruments Co., Ltd. | II | Jul-26-2018 |
| 12 | International Medsurg Connection, Inc. | II | Aug-04-2017 |
| 13 | MHC Medical Products LLC | II | May-09-2018 |
| 14 | Merz Aesthetics, Inc. | III | Jun-26-2015 |
| 15 | Myco Medical Supplies Inc | II | Dec-17-2015 |
| 16 | Owen Mumford USA, Inc. | II | Jan-17-2018 |
| 17 | Smiths Medical ASD Inc. | II | Jul-03-2017 |
| 18 | Smiths Medical ASD, Inc. | II | Dec-30-2014 |
| 19 | Teleflex Medical | III | Apr-04-2017 |
| 20 | Vidacare Corporation | II | Jun-15-2015 |
| 21 | Vidacare Corporation | II | Sep-22-2014 |
| 22 | Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc. | II | Feb-21-2018 |
| 23 | Waismed Ltd | II | Aug-27-2016 |