# K965080: Anspach Micromax System

- Pathway: 510(k) (Traditional)
- Applicant: The Anspach Effort, Inc.
- Decided: Jan 10, 1997 after 22 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 4 cite it directly.
0 of 7 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
- K131053: Anspach Xmax, EMAX2 and EMAX2 Plus System with Otologic Attachment System (2013), 1 descendant of its own
- K022907: Anspach Powered Kerrison System (PKS) (2002), 1 descendant of its own
- K180063: OCM-G1 Attachment (2018), 0 descendants of its own
- K062413: Aesculap Pneumatic Kerrison (2006), 0 descendants of its own
- K042974: Medicon Vipair High Speed System (2005), 0 descendants of its own

## Recalls of this device
- Oct 6, 2016 · Class II · Z-1944-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1945-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1995-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- May 6, 2013 · Class II · Z-0779-2014: Product did not reach expected sterility assurance level
- Apr 25, 2013 · Class II · Z-0655-2014: The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (
- Apr 25, 2013 · Class II · Z-0656-2014: The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (
- Nov 28, 2012 · Class II · Z-1898-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
- Nov 28, 2012 · Class II · Z-1897-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
- Nov 28, 2012 · Class II · Z-1894-2014: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
- May 18, 2007 · Not classified · Z-1008-2007: The white film portion of the sterile pouch may become brittle prior to the expiry date compromising the sterility of the product.
- Dec 18, 2006 · Not classified · Z-1039-2008: Incorrect Sterilization Process --The Operating Manual for the product contains an incorrect statement regarding the sterilization of the Autolube foot control. The manual states that the product can 

Source page: https://510kreport.com/device/K965080
Methodology: https://510kreport.com/methodology