510(k) K181447
- Device
- Safety Insulin Needle For Single Use
- Applicant
- Berpu Medical Technology Co., Ltd
- 510(k) number
- K181447
- Product code
- FMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-03-12
- Date received
- 2018-06-01
- 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
- Jundong Tan
- Address
- # 14 Xingji Rd., Yongxiing St., Longwan District Wenzhou CN 325000 325000
FDA Registration Numbers#
- 1035236
- 1063851
- 1048735
- 3012944064
- 3013298431
- 3034667025
- 3004425647
- 3003915875
- 3044026004
- 3005674478
- 3009746061
- 1625425
- 9613662
- 1319639
- 3005798905
- 3006762440
- 3013187142
- 3012551896
- 3030419987
- 3003589279
- 3013429260
- 3017907716
- 3015620563
- 3004417597
- 1213809
- 1832816
- 3009518015
- 3003916417
- 3010384323
- 3015142721
- 3035111606
- 1930034
- 9617604
- 1058955
- 1223004
- 1623486
- 3004192065
- 9612501
- 3009761558
- 3007344957
- 3004127962
- 1644312
- 3012104670
- 3015724078
- 3010872792
- 3012410077
- 1224960
- 3007097064
- 3015142802
- 9613304
- 3012461127
- 3035387162
- 3017654330
- 2025816
- 3014479313
- 3003542872
- 1911916
- 9615588
- 3005841027
- 1820334
- 3015176887
- 1928237
- 3010131137
- 3018094310
- 3029905131
- 3010155648
- 1034525
- 3010419931
- 9680222
- 3010055973
- 3010621964
- 8020347
- 3038110468
- 9681821
- 3005941719
- 9617594
- 3016685880
- 8020785
- 3009578786
Source Documents#
Other 510(k) Records For Product Code FMI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260739 | Profoject™ Pen Needles (Model A; Model B) | CMT Health PTE., Ltd. | 2026-07-15 |
| 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 |
Legacy Summary#
summary