510(k) K172763
- Device
- Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle With Holder, Safety Blood Collecting Needle With Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set With Holder, Safety Blood Collecting Set
- Applicant
- Zhejiang Kindley Medical Devices Co.,Ltd
- 510(k) number
- K172763
- Product code
- FMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-06-04
- Date received
- 2017-09-13
- 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
- Yong Zhang
- Address
- #758, 5th Binhai Rd. Binhai Industrial Park, Longwan District Wenzhou CN 325025 325025
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#
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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