# K943575: B-D Guardian Nestable Sharps Collectors

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Oct 14, 1994 after 84 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 5 cite it directly.
0 of 17 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
- K130281: Oak Ridge Products Sharp Container (2013), 7 descendants of its own
- K072667: Sharps Away Disposable Container (2007), 4 descendants of its own
- K161180: Oak Ridge Products Sharps Containers (2016), 3 descendants of its own
- K180984: Maxcon Sharps Container (2019), 2 descendants of its own
- K131708: Bwcsh-1 Sharps Container (2014), 1 descendant of its own

Source page: https://510kreport.com/device/K943575
Methodology: https://510kreport.com/methodology