# K002040: FMS Solo

- Pathway: 510(k) (Traditional)
- Applicant: Future Medical Systems, Inc.
- Decided: Sep 11, 2000 after 68 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 3 cite it directly.
0 of 11 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
- K130169: FMS Vue Fluid Managment System, FMS Connect Interface Cable (2013), 5 descendants of its own
- K192921: Zeos Aqua Vision Pump and tube (2020), 2 descendants of its own
- K050580: Smith & Nephew Intelijet Fluid Management Systems (2005), 2 descendants of its own
- K203480: DOUBLEFLO system (2021), 1 descendant of its own
- K051326: Smith & Nephew 25 Fluid Management System (2005), 1 descendant of its own

## Recalls of this device
- 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/K002040
Methodology: https://510kreport.com/methodology