Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)
FDA 510(k) clearance K260933 · decided 2026-08-07
Clearance details
- K-number
- K260933
- Device name
- Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)
- Applicant
- Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2026-03-20
- Decision date
- 2026-08-07
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Hangzhou, CN
- 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 |
|---|---|---|
| Profoject™ Dual-Safety Pen Needles (K261829) | CMT Health PTE., Ltd. | 2026-07-29 |
| Profoject™ Pen Needles (Model A; Model B) (K260739) | CMT Health PTE., Ltd. | 2026-07-15 |
| Profoject™ Safety Pen Needles (K260855) | CMT Health PTE., Ltd. | 2026-06-10 |
| Verisafe Safety Sterile Needles (SSN) (K254273) | Promisemed Hangzhou Meditech Co., Ltd. | 2026-04-16 |
| Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle (K252908) | Sandstone Medical (Suzhou), Inc. | 2026-03-25 |
| PRESSONE™ (K253047) | Nipro Medical Corporation | 2026-03-24 |
| Safety Pen Needle (K253622) | Ningbo Medsun Medical Co., Ltd. | 2026-03-18 |
| Pen Needle (K252886) | Hh Global Technology, Inc. | 2026-01-06 |
| Pen Injector Needle 32.5 (K250700) | Terumo Corporation | 2025-11-21 |
| Profoject™ Disposable Needle (K252631) | CMT Health PTE., Ltd. | 2025-10-16 |
| Intraosseous Infusion Needles (K250724) | Spectrum Vascular | 2025-07-30 |
| TSK SELECT™ Needle (K250284) | Tsk Laboratory, Japan | 2025-07-24 |
Recalls involving this device
No recalls on record reference this clearance.