510(k) K222124
- Device
- Sterile Hypodermic Syringe With/without Needle, Hypodermic Needle
- Applicant
- Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd
- 510(k) number
- K222124
- Product code
- FMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-11-04
- Date received
- 2022-07-18
- 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
- Bingyi Xiang
- Address
- # 2 Guanyin Rd., Economic Development Zone, Taihu Anqing City CN 246400 246400
FDA Registration Numbers#
- 3021169199
- 3010515547
- 3034669683
- 3015727296
- 3011676762
- 9613304
- 8020347
- 3038110468
- 3021286079
- 3036722184
- 3003902955
- 9681835
- 1035236
- 9611446
- 9615908
- 3014421917
- 1420054
- 3017907716
- 3004961578
- 1832816
- 3012354669
- 1923569
- 3013633270
- 3043531632
- 3010026090
- 1930034
- 3007207906
- 3012854006
- 3030714660
- 3022699058
- 3031259044
- 3027338968
- 3020460367
- 3011287770
- 3009888344
- 3011137372
- 3038294399
- 1055236
- 1647137
- 1450392
- 3010864832
- 3005841027
- 3008998256
- 3007441619
- 3007817041
- 3003681915
- 3043709866
- 2427500
- 3029755538
- 3030447506
- 3003974574
- 3013429260
- 3007939342
- 3009518015
- 3007508552
- 1828424
- 3030089798
- 2032810
- 1644312
- 3019004087
- 2032098
- 9681822
- 2031093
- 3008789114
- 1018233
- 1219611
- 1066444
- 1054241
- 3001728571
- 3004099493
- 3006371704
- 3042953454
- 1319639
- 9616482
- 1000523114
- 3009495876
- 2011171
- 3012438919
- 1410248
Source Documents#
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#
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