510(k) K081547
- Device
- BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC
- Applicant
- BIO-MED U.S.A., INC.
- 510(k) number
- K081547
- Product code
- FMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-09-08
- Date received
- 2008-06-02
- Regulation
- 880.5860
- Classification name
- Syringe, Piston
- 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
- YOUNG CHI
- Address
- 111 Ellison St. Paterson NJ US 07505 07505
FDA Registration Numbers#
- 3005853033
- 3010405396
- 1424263
- 3010220595
- 3004143450
- 1000359047
- 3008496303
- 1530671
- 3004111573
- 3003589911
- 3020778
- 3008717264
- 3002808227
- 3012495575
- 3002763532
- 3007895168
- 3004099493
- 9680425
- 1647137
- 3011015097
- 3009551627
- 3011689956
- 3014615644
- 3015485283
- 3005246939
- 8010674
- 3003704957
- 1319660
- 3014579161
- 3015550451
- 3010041511
- 3013176080
- 3022699058
- 3015542154
- 3006498370
- 1911916
- 3027339877
- 1056186
- 1319639
- 3010864832
- 2246552
- 3038220293
- 9611594
- 3016965628
- 3005669815
- 3008837339
- 9611024
- 3003120666
- 3012261967
- 3013576619
- 3015474594
- 1036836
- 3005798905
- 3012944064
- 1219930
- 2032227
- 2030624
- 1055236
- 1928237
- 3045857302
- 1720929
- 3010667733
- 1037885
- 3010966701
- 1417485
- 3009756153
- 9681413
- 3006795797
- 1064858
- 3007407626
- 2320767
- 3010175289
- 3034669683
- 1423537
- 3006142663
- 3034676720
- 3013496867
- 1225112
- 8043792
- 8040619
Source Documents#
Other 510(k) Records For Product Code FMF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. | 2026-06-18 |
| K260514 | Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle | CMT Health PTE., Ltd. | 2026-06-12 |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) | Hlb Lifescience Co., Ltd. | 2026-05-21 |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) | Chirana T.Injecta,A.S. | 2026-04-17 |
| K253068 | Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe | CMT Health PTE., Ltd. | 2026-02-23 |
| K253769 | Instylla Delivery Kit | Instylla, Inc. | 2025-12-22 |
| K252518 | DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate | 2025-12-17 |
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle | Exelint International, Co. | 2025-12-12 |
| K250192 | Verisafe Safety Retractable Insulin Syringes | Promisemed Hangzhou Meditech Co., Ltd. | 2025-12-10 |
| K250853 | Merit Syringe | Merit Medical Systems, Inc. | 2025-11-04 |
| K250510 | Sure-Fine Insulin Syringes | Shina Med Corporation | 2025-10-15 |
| K243660 | Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); Monojec | Cardinalhealth | 2025-08-22 |
| K251350 | BD Plastipak™ Syringe | Becton, Dickinson and Company | 2025-07-29 |
| K252033 | Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle | CMT Health PTE., Ltd. | 2025-07-25 |
| K250733 | 3DOSE 1ml Syringe | Bimed Teknik Aletler Sanayi & Ticaret A.S. | 2025-07-03 |
Legacy Summary#
summary
FDA Review#
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