# K820164: Empty Sterile Carpuject

- Pathway: 510(k) (Traditional)
- Applicant: Sterling Drug, Inc.
- Decided: Feb 24, 1982 after 35 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 4 cite it directly.
0 of 9 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
- K063180: Isecure Syringe Cartridge Holder (2006), 5 descendants of its own
- K180345: Uroject12 Syringe Lever (2018), 2 descendants of its own
- K190987: Uroject12 Syringe Lever (2019), 1 descendant of its own
- K083583: Xpresse Injection System (2009), 1 descendant of its own
- K203321: Cystoject Syringe Lever (2020), 0 descendants of its own

Source page: https://510kreport.com/device/K820164
Methodology: https://510kreport.com/methodology