Definition: A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure.
| Device Type ID | 824 |
| Device Name | Blood Pressure Cuff |
| Regulation Description | Blood Pressure Cuff. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1120 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DXQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 824 |
| Device | Blood Pressure Cuff |
| Product Code | DXQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Blood Pressure Cuff. |
| CFR Regulation Number | 870.1120 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ANDON HEALTH CO.,LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ICU MEDICAL SALES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KOVEN TECHNOLOGY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDLINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDLINE INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NINGBO FREE TRADE ZONE TENSO MEDICAL INSTRUMENTS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS MEDICAL SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PINGHU SAMA MEDICAL PACKING CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHANGHAI GOAHUI RUBBER AND PLASTIC COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN VISTAR MEDICAL SUPPLIES CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SPACELABS HEALTHCARE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUZHOU SUNSPIRIT CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Material Separation | 53 |
Unraveled Material | 23 |
Break | 22 |
Flaked | 14 |
Difficult To Remove | 12 |
Material Fragmentation | 7 |
Material Frayed | 6 |
Appropriate Term/Code Not Available | 6 |
Uncoiled | 5 |
Peeled / Delaminated | 4 |
Material Deformation | 3 |
Kinked | 3 |
Fracture | 3 |
Degraded | 2 |
Occlusion Within Device | 2 |
Wire | 2 |
Difficult To Advance | 2 |
Stretched | 2 |
Split | 2 |
Detachment Of Device Or Device Component | 2 |
Sticking | 2 |
Device Contamination With Chemical Or Other Material | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Unintended Movement | 1 |
Detachment Of Device Component | 1 |
Human Factors Issue | 1 |
Torn Material | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Retraction Problem | 1 |
Use Of Device Problem | 1 |
Deformation Due To Compressive Stress | 1 |
Material Split, Cut Or Torn | 1 |
Bent | 1 |
Device Operates Differently Than Expected | 1 |
Material Twisted / Bent | 1 |
Guidewire | 1 |
Material Integrity Problem | 1 |
| Total Device Problems | 193 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ICU Medical, Inc. | II | May-09-2018 |