Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)
FDA 510(k) clearance K192681 · decided 2020-07-28
Clearance details
- K-number
- K192681
- Device name
- Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)
- Applicant
- Jiangsu Kangbao Medical Equipment Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-26
- Decision date
- 2020-07-28
- Days to decision
- 306 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Yangzhou, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Jiangsu Kangbao Medical Equipment Co.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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.