# K951843: Ref. 4102CV Intermediary Tubing, Ref. 4509CV Sterile Zone Kit

- Pathway: 510(k) (Traditional)
- Applicant: Future Medical Systems, Inc.
- Decided: Jul 14, 1995 after 85 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K132883: Hemodia Arthroscopy Pump Tube Sets (Hats) (2013), 0 descendants of its own

## Recalls of this device
- Aug 29, 2013 · Class II · Z-0191-2014: 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 
- Dec 3, 2010 · Not classified · Z-1948-2011: Product sterility may be compromised due to breach in sterile packaging
- Dec 3, 2010 · Not classified · Z-1946-2011: Product sterility may be compromised due to breach in sterile packaging

Source page: https://510kreport.com/device/K951843
Methodology: https://510kreport.com/methodology