# K051326: Smith & Nephew 25 Fluid Management System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 15, 2005 after 26 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K950035 (1996). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031605: Intelijet Fluid Management System Hermes-Ready, Smith & Nephew, Inc. (2003) Summary page 1.
- K050580: Smith & Nephew Intelijet Fluid Management Systems, Smith & Nephew Endoscopy, Inc. (2005) Summary page 1.

## Most influential descendants
- K171794: Smith & Nephew 25 Fluid Management System (2017), 0 descendants of its own

## Recalls of this device
- May 27, 2009 · Not classified · Z-2078-2009: The sterility of the device cannot be assured
- May 27, 2009 · Not classified · Z-2077-2009: The sterility of the device cannot be assured
- Aug 7, 2008 · Not classified · Z-2450-2008: Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use.
- Aug 7, 2008 · Not classified · Z-2451-2008: Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use.
- Aug 7, 2008 · Not classified · Z-2448-2008: Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use.
- Aug 7, 2008 · Not classified · Z-2449-2008: Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use.

## Indications for use
The Smith & Nephew 25 Fluid Management System is indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids in the knee, shoulder, hip and small joints to maintain intra-articular pressure for uniform distension and clear visualization of the surgical site.

Source page: https://510kreport.com/device/K051326
Methodology: https://510kreport.com/methodology