510(k) K252631
- Device
- Profoject™ Disposable Needle
- Applicant
- CMT Health PTE., Ltd.
- 510(k) number
- K252631
- Product code
- FMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-10-16
- Date received
- 2025-08-20
- 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
- N
Applicant Contact#
- Contact
- Monica Ma
- Address
- 150 Beach Rd., #28-05 Gateway W. SG 189720 189720
FDA Registration Numbers#
- 3010405396
- 3010220595
- 3030446844
- 1623486
- 3004143450
- 9617592
- 3004111573
- 3003589911
- 9616791
- 3004138517
- 3002808227
- 3010223109
- 3007895168
- 3004099493
- 1647137
- 3008102042
- 1213680
- 1066741
- 3011689956
- 3015485283
- 3005246939
- 3021286079
- 3017210488
- 3012854006
- 3011617315
- 3014579161
- 3003824562
- 1221765
- 3010041511
- 3022699058
- 3014656668
- 1911916
- 1056186
- 1319639
- 3010864832
- 1222780
- 3026211706
- 3005669815
- 3008780388
- 3003120666
- 9610849
- 3009504230
- 3008729892
- 1036836
- 1125230
- 3005798905
- 3012944064
- 3027605735
- 1055236
- 3000214934
- 1928237
- 8020347
- 3010966701
- 1417485
- 3009518015
- 3009756153
- 3012187743
- 9681413
- 1064858
- 3010175289
- 3034669683
- 1423537
- 3013429260
- 9612501
- 3006142663
- 1820334
- 3013496867
- 8043792
- 3030419987
- 8040619
- 3006850123
- 3014421917
- 1410248
- 3005941719
- 3009077131
- 1047429
- 3013160284
- 3010462274
- 1915484
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 |
| 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 |