# K943134: B-D Guardian Nestable Sharps Collectors

- Pathway: 510(k) (Traditional)
- Applicant: Med-Safe Systems, Inc.
- Decided: Nov 7, 1994 after 131 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 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
- K112774: BD Recykleen Sharps Collectors (2012), 3 descendants of its own
- K132476: Sharps Container (2014), 2 descendants of its own
- K151249: Pureway Sharps Collector 1.2 Gallon,  Pureway Sharps Collector 2 Gallon, Pureway Sharps Collector 3 Gallon (2015), 1 descendant of its own
- K140285: B Travelsavvy Sharps Container (2014), 1 descendant of its own
- K251874: PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K943134
Methodology: https://510kreport.com/methodology