# K011297: Nipro Safetouch Scalp Vein and Blood Collection Set

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corp.
- Decided: Jun 20, 2001 after 51 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K080235: Safety Infusion Set (2008), 7 descendants of its own
- K121908: Safety Infusion Set (2012), 6 descendants of its own
- K173757: VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set (2018), 2 descendants of its own
- K170276: Safety Blood Collection Device for Single Use (2017), 2 descendants of its own
- K214075: Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) (2022), 1 descendant of its own

## Recalls of this device
- May 4, 2013 · Class II · Z-1834-2014: There is a possibility of a crack in the CP luer connector. The position of the crack is at the connection site of the CP luer connector and the tubing. The crack could cause or contribute to leakage 

Source page: https://510kreport.com/device/K011297
Methodology: https://510kreport.com/methodology