Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
FDA 510(k) clearance K253112 · decided 2026-05-21
Clearance details
- K-number
- K253112
- Device name
- Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
- Applicant
- Hlb Lifescience Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-24
- Decision date
- 2026-05-21
- Days to decision
- 239 days
- Clearance type
- Special
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Anseong-Si, KR
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Hlb Lifescience Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.