# K921636: Vacutainer (R) Brand Safety-Lok Blood Collect Set

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Apr 29, 1992 after 23 days
- Product code: GIM (Tubes, Vacuum Sample, With Anticoagulant)
- 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
No predicates in its family tree.
24 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K011984: BD Vacutainer Push Button Blood Colection Set (2001), 23 descendants of its own
- K022875: Modification to BD Vacutainer Push Button Blood Collection Set (2002), 18 descendants of its own
- K030573: BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342, 367335, 367341 (2003), 17 descendants of its own
- K153309: BD Vacutainer UltraTouch Push Button Blood Collection Set (2016), 6 descendants of its own
- K192247: Steripath Gen2 Blood Collection System (2020), 5 descendants of its own

Source page: https://510kreport.com/device/K921636
Methodology: https://510kreport.com/methodology