510(k) K123987
- Device
- IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET
- Applicant
- INNOVATIVE MEDICAL TECHNOLOGIES, INC.
- 510(k) number
- K123987
- Product code
- FMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-08-27
- Date received
- 2012-12-26
- Regulation
- 880.5570
- Classification name
- Needle, Hypodermic, Single Lumen
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRAD BROWN
- Address
- 15059 Cedar St. Leawood KS US 66224 66224
FDA Registration Numbers#
- 3012598266
- 3008717264
- 3004597845
- 3004425647
- 3030626857
- 3013221738
- 1647137
- 2018685
- 9680794
- 3007616112
- 3018507299
- 1911916
- 3001452053
- 3009963993
- 3006850222
- 8021538
- 1915484
- 3024537844
- 1060680
- 3020294761
- 3012307300
- 3017210488
- 3002807968
- 2434982
- 1219611
- 2321034
- 9617475
- 3010131137
- 9610847
- 9611446
- 3012536737
- 3015453963
- 1054811
- 3008449424
- 2030624
- 3026940910
- 3022147580
- 3016884191
- 3033589330
- 8010026
- 1058602
- 3016844398
- 3002807408
- 3010220595
- 3001124136
- 2320762
- 1054241
- 3028019212
- 3013652330
- 3020831613
- 8041187
- 1917413
- 3008272066
- 3017509841
- 3029901632
- 1710034
- 3004416208
- 3003120666
- 2032521
- 3008307705
- 3013513377
- 3013187142
- 3002682307
- 9615588
- 3034667025
- 3014570560
- 9681572
- 2245437
- 1036836
- 3015309643
- 3022964615
- 3013248161
- 3043226252
- 1319639
- 1531062
- 2024311
- 3010419931
- 3015620563
- 9613662
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FMI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254273 | Verisafe Safety Sterile Needles (SSN) | Promisemed Hangzhou Meditech Co., Ltd. | 2026-04-16 |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle | Sandstone Medical (Suzhou), Inc. | 2026-03-25 |
| K253047 | PRESSONE™ | Nipro Medical Corporation | 2026-03-24 |
| K253622 | Safety Pen Needle | Ningbo Medsun Medical Co., Ltd. | 2026-03-18 |
| K252886 | Pen Needle | Hh Global Technology, Inc. | 2026-01-06 |
| K250700 | Pen Injector Needle 32.5 | Terumo Corporation | 2025-11-21 |
| K252631 | Profoject™ Disposable Needle | CMT Health PTE., Ltd. | 2025-10-16 |
| K250724 | Intraosseous Infusion Needles | Spectrum Vascular | 2025-07-30 |
| K250284 | TSK SELECT™ Needle | Tsk Laboratory, Japan | 2025-07-24 |
| K251447 | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) | Terumo Europe N.V. | 2025-07-08 |
| K243309 | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | Terumo Europe N.V. | 2025-05-29 |
| K240355 | FROG (Filter Removal of Glass) | Carrtech Corp | 2025-04-18 |
| K243581 | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) | Terumo Europe N.V. | 2025-04-04 |
| K250658 | SureFine Pen Needle | Shina Med Corporation | 2025-04-03 |
| K243806 | Safety Winged Blood Collection Sets | Promisemed Hangzhou Meditech Co., Ltd. | 2025-01-10 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases