# K954465: FMS Duo

- Pathway: 510(k) (Traditional)
- Applicant: Future Medical Systems, Inc.
- Decided: Nov 9, 1995 after 45 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
46 later devices descend from it; 12 cite it directly.
0 of 47 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
- K030402: Arthroscopy Pump, Model A107 (2003), 29 descendants of its own
- K062380: Flosimple Arthroscopy Pump A120 (2006), 15 descendants of its own
- K112642: Aquilex Fluid Control System H112 (2012), 14 descendants of its own
- K123732: Hysteroscopy Pump HM6 (2013), 6 descendants of its own
- K041824: X-Treme Arthroscopic Pump and Shaver System (2005), 6 descendants of its own

## Recalls of this device
- Nov 20, 2015 · Class II · Z-0658-2016: Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
- Aug 29, 2013 · Class II · Z-0192-2014: Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may 

Source page: https://510kreport.com/device/K954465
Methodology: https://510kreport.com/methodology