510(k) K161950
- Device
- Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd.
- 510(k) number
- K161950
- Product code
- FMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-05-11
- Date received
- 2016-07-15
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Keshin Hu
- Address
- # 18 Haishu Rd. Future Sci-Tech Park, Yuhang District Hangzhou CN ZJ571 ZJ571
FDA Registration Numbers#
- 3000214934
- 1450392
- 3022699058
- 3013221738
- 3014649053
- 3018507299
- 1722458
- 3019012929
- 3009498548
- 3010041511
- 1923569
- 1219611
- 3017494520
- 3008729892
- 3008729549
- 3014819517
- 3014165712
- 3043531632
- 3010131137
- 9610847
- 3026478941
- 3007895168
- 3008449424
- 8010026
- 1058602
- 3018681450
- 3010220595
- 1417485
- 2245270
- 3007384659
- 3020831613
- 8041187
- 3008780388
- 3017509841
- 3007392007
- 3013481097
- 3013187142
- 3007590959
- 9614279
- 9615588
- 3005669815
- 3007207906
- 3010175289
- 1313700
- 3031259044
- 3012680643
- 3007939342
- 3021186226
- 9615908
- 1035236
- 3012551896
- 1319211
- 1820334
- 3003915875
- 3015058854
- 3003895930
- 9616567
- 3006942524
- 3004192065
- 3013557562
- 3011689956
- 3023339256
- 3030201489
- 3007829657
- 3014747754
- 8041145
- 3009746061
- 1066741
- 1417592
- 1450743
- 1625685
- 3023359743
- 3006371704
- 9681835
- 3008009298
- 3031233007
- 8043385
- 3001728571
- 8020040
Source Documents#
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#
summary
FDA Review#
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