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#
- 3010131137
- 3012421607
- 3006950086
- 3013055489
- 3008717264
- 3004597845
- 8020616
- 3013188547
- 3042871620
- 3033589330
- 3011088743
- 9617475
- 1832216
- 3003974574
- 2024311
- 2245437
- 1917413
- 3018507299
- 3016904853
- 2243072
- 1424263
- 3030626857
- 3013187142
- 3001452053
- 3012116434
- 1915484
- 3010531069
- 3006425876
- 3019004087
- 8021538
- 3010419931
- 3015997711
- 3008733163
- 3005587132
- 3027553380
- 3010621964
- 3015058854
- 3014456066
- 3013248161
- 2648727
- 3001124136
- 9616567
- 3006285950
- 3009889060
- 3020294761
- 3014579161
- 8010026
- 8020040
- 3004140833
- 3008272066
- 1036836
- 3002637618
- 3014680809
- 3013298431
- 3024537844
- 3029901632
- 9681572
- 3016884191
- 3031789039
- 3009732568
- 1054811
- 3003120666
- 2434982
- 3038772401
- 1055927
- 3030733800
- 1220477
- 3044026004
- 1000163068
- 3004416208
- 3005674478
- 3017210488
- 3011287770
- 1933913
- 1125230
- 3017923561
- 3004425647
- 3016661372
- 3013221738
- 3009976527
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