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#
- 1423507
- 8023060
- 3030626857
- 3021169199
- 3010515547
- 3029901632
- 1220477
- 3013187142
- 3001124136
- 3031789039
- 9680222
- 3010220595
- 3013513377
- 3009732568
- 3000268902
- 3016844398
- 1047843
- 3017210488
- 2030624
- 3009963993
- 3030243919
- 3014263632
- 3003120666
- 3012502601
- 3020294761
- 9681835
- 3016904853
- 3038356900
- 3031233007
- 1055927
- 9611446
- 1423537
- 9615588
- 3004140833
- 9615908
- 3027553380
- 1043214
- 3043051314
- 3014456066
- 8020616
- 3010194621
- 3015972753
- 3017923561
- 3002807408
- 3018507299
- 2243072
- 9610847
- 3022728142
- 3014579161
- 3001452053
- 3023228837
- 2024311
- 3009889060
- 3020460367
- 3005910889
- 3011689956
- 3012116434
- 8021538
- 3011287770
- 1832216
- 9681572
- 1036781
- 1055236
- 9617604
- 3010419931
- 1647137
- 3012598266
- 2648727
- 3024537844
- 3034667025
- 3008449424
- 3013248161
- 3015453963
- 9617475
- 1933913
- 2321034
- 1054811
- 3041276591
- 1531062
- 3000247873
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FMI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260855 | Profoject™ Safety Pen Needles | CMT Health PTE., Ltd. | 2026-06-10 |
| 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 |
Legacy Summary#
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FDA Review#
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