# K944025: Surgical Instrument Tray

- Pathway: 510(k) (Traditional)
- Applicant: Riley Medical, Inc.
- Decided: Nov 22, 1994 after 97 days
- Product code: FSM (Tray, Surgical, Instrument)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
152 later devices descend from it; 4 cite it directly.
1 of 153 devices in its family (counting itself) has 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
- K990761: Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette (1999), 150 descendants of its own
- K012105: Polyvac Surgical Instrument Delivery System (2002), 149 descendants of its own
- K993535: Metapak Multi-Purpose Instrument Tray (2001), 130 descendants of its own
- K033222: Olympus Sterilization Trays (2004), 58 descendants of its own
- K040223: Polyvac Instrument Delivery System (2004), 46 descendants of its own

Source page: https://510kreport.com/device/K944025
Methodology: https://510kreport.com/methodology