# K030576: Anspach Irrigation Pump and Irrigation Pump II

- Pathway: 510(k) (Traditional)
- Applicant: The Anspach Effort, Inc.
- Decided: May 21, 2003 after 86 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- 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 K852143 (1985). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011444: Anspach Emax Drill System, The Anspach Effort, Inc. (2001)
- K852143: Hall Irrigation System, Hall Surgical, Division of Zimmer, Inc. (1985) Summary page 2.

## Most influential descendants
- K061108: Stryker Auto Irrigation System (2007), 0 descendants of its own
- K063688: Surgical Irrigation System, Irrigation Tube (2007), 0 descendants of its own

## Recalls of this device
- Dec 3, 2013 · Class II · Z-1629-2014: The Irrigation Clips were assembled with the incorrect (smaller) clips.

## Indications for use
Anspach Surgical Irrigation Systems are indicated for use with Anspach Surgical Motor Systems for providing controlled, cooling irrigation during cutting, shaping and removal of bone, including bones of the skull and spine.

Source page: https://510kreport.com/device/K030576
Methodology: https://510kreport.com/methodology