Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle
FDA 510(k) clearance K232950 · decided 2024-06-12
Clearance details
- K-number
- K232950
- Device name
- Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle
- Applicant
- Perfect Medical Industry (Vn) Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-20
- Decision date
- 2024-06-12
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Ho Chi Minh City, VN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Ultra-Fine™ SAFETY Insulin Syringe (K260208) | embecta Medical II, LLC | 2026-07-13 |
| Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe (K253110) | Sol-Millennium Medical, Inc. | 2026-06-18 |
| Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle (K260514) | CMT Health PTE., Ltd. | 2026-06-12 |
| Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) (K253112) | Hlb Lifescience Co., Ltd. | 2026-05-21 |
| Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) (K252279) | Chirana T.Injecta,A.S. | 2026-04-17 |
| Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe (K253068) | CMT Health PTE., Ltd. | 2026-02-23 |
| Instylla Delivery Kit (K253769) | Instylla, Inc. | 2025-12-22 |
| DuoprossTM Smart Cap (Type I) (K252518) | Duopross Meditech Corporate | 2025-12-17 |
| EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle (K251089) | Exelint International, Co. | 2025-12-12 |
| Verisafe Safety Retractable Insulin Syringes (K250192) | Promisemed Hangzhou Meditech Co., Ltd. | 2025-12-10 |
| Merit Syringe (K250853) | Merit Medical Systems, Inc. | 2025-11-04 |
| Sure-Fine Insulin Syringes (K250510) | Shina Med Corporation | 2025-10-15 |
Recalls involving this device
No recalls on record reference this clearance.