# K093409: Powerpump Arthroscopy System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Vision AB
- Decided: Feb 24, 2010 after 114 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
Longest line of descent: 1 generation back to K954465 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954465: FMS Duo, Future Medical Systems, Inc. (1995) Summary page 1.

## Recalls of this device
- May 10, 2016 · Class II · Z-2705-2016: Sterility of device may be compromised due to sterile package breakage.

## Indications for use
The PowerPump is a dual arthroscopic pump system intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures.

Source page: https://510kreport.com/device/K093409
Methodology: https://510kreport.com/methodology