# K081229: Saf-T Closed Blood Collection System with Saf-Holder Device, with 21G, 23G, 25G Saf-T Wing

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Jul 21, 2008 after 82 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K895367 (1989). 5 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072783: Saf-T Closed Blood Collection System with Saf-Holder Device, Model 99200, Saf-T Closed Blood Collection System with, Smiths Medical Asd, Inc. (2007) Summary page 1.
- K922445: Vacu-Pro, Concord/Portex (1992) Summary page 1.

## Most influential descendants
- K142946: TIVA (2015), 8 descendants of its own
- K152924: TIVA¿ (2016), 7 descendants of its own
- K163508: PIVO (2017), 6 descendants of its own
- K190604: PIVO (2019), 5 descendants of its own
- K193569: Pivo (TM) (2020), 3 descendants of its own

## Indications for use
The Saf-T Closed Blood Collection System® device is attached to a peripheral IV catheter at the time of IV catheter placement for use as a direct blood draw device into a vacuum tube or to allow a syringe blood draw and transfer to fill vacuum tubes. The Saf-T Closed Blood Collection Systenm®device is inteaded for use as a direct blood draw device into a vacuum tube or to allow a syringe blood draw and transfer to fill vacuum tubes.

Source page: https://510kreport.com/device/K081229
Methodology: https://510kreport.com/methodology