510(k) · Cleared
Recalled · Class II · 2016Anspach Micromax System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Anspach Effort, Inc. · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Cleared on Jan 10, 1997 after a 22-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it. It has been recalled 11 times.
- Decided
- Jan 10, 1997
- Review
- 22 days
- Class
- Class II
- Product code
- ERL
- Recalls
- 11
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK965080 Anspach Micromax SystemThe Anspach Effort, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK131053 Anspach Xmax, EMAX2 and EMAX2 Plus System with Otologic Attachment…The Anspach Effort, Inc. · 2013 · Recalled
- Descendant · cites it directly · 1 of its ownK022907 Anspach Powered Kerrison System (PKS)The Anspach Effort, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK180063 OCM-G1 AttachmentThe Anspach Effort, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK062413 Aesculap Pneumatic KerrisonAesculap, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK042974 Medicon Vipair High Speed SystemMedicon EG · 2005
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K131053Anspach Xmax, EMAX2 and EMAX2 Plus System with Otologic Attachment SystemThe Anspach Effort, Inc. · 2013 · cites it directly1descendant
- K022907Anspach Powered Kerrison System (PKS)The Anspach Effort, Inc. · 2002 · cites it directly1descendant
- K180063OCM-G1 AttachmentThe Anspach Effort, Inc. · 2018 · 2 generations on0descendants
- K062413Aesculap Pneumatic KerrisonAesculap, Inc. · 2006 · 2 generations on0descendants
- K042974Medicon Vipair High Speed SystemMedicon EG · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K965080 | Anspach Micromax System | The Anspach Effort, Inc. | 1997 | — |
| +1 | K131053 | Anspach Xmax, EMAX2 and EMAX2 Plus System with Otologic Attachment System | The Anspach Effort, Inc. | 2013 | 3 |
| +1 | K022907 | Anspach Powered Kerrison System (PKS) | The Anspach Effort, Inc. | 2002 | — |
| +2 | K180063 | OCM-G1 Attachment | The Anspach Effort, Inc. | 2018 | — |
| +2 | K062413 | Aesculap Pneumatic Kerrison | Aesculap, Inc. | 2006 | — |
| +1 | K042974 | Medicon Vipair High Speed System | Medicon EG | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ERL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ERL device
- #1 K243280 Piezomed Pro (Piezomed Pro module M-PM100…score 12.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 6, 2016 | Class II | Z-1944-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1945-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| Oct 6, 2016 | Class II | Z-1995-2017 | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| May 6, 2013 | Class II | Z-0779-2014 | Unknown/Undetermined by firm | Product did not reach expected sterility assurance level |
| Apr 25, 2013 | Class II | Z-0655-2014 | Component design/selection | 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 (PRV) due to the hand piece's outer… |
| Apr 25, 2013 | Class II | Z-0656-2014 | Component design/selection | 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 (PRV) due to the hand piece's outer… |
| Nov 28, 2012 | Class II | Z-1898-2014 | Process design | 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 | Process design | 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 | Process design | 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 | Nonconforming Material/Component | 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 | Labeling False and Misleading | 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 withstand ETO sterilization, but there… |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K131053 (The Anspach Effort, Inc., 2013) has gone furthest, with 1 descendant of its own.
How does its category compare?
All ERL devicesERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ERL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ERL
191in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ERL
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ERL
1,469in 2025
MAUDE reports naming product code ERL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 112 |
| 2008 | 6 | 181 | 0 | 60 |
| 2009 | 1 | — | 1 | 249 |
| 2010 | 0 | — | 0 | 444 |
| 2011 | 0 | — | 0 | 1,068 |
| 2012 | 2 | — | 0 | 1,379 |
| 2013 | 2 | — | 3 | 3,231 |
| 2014 | 1 | — | 0 | 1,975 |
| 2015 | 3 | 86 | 0 | 2,630 |
| 2016 | 4 | 180 | 0 | 1,455 |
| 2017 | 2 | — | 0 | 999 |
| 2018 | 1 | — | 0 | 1,380 |
| 2019 | 1 | — | 0 | 2,515 |
| 2020 | 1 | — | 5 | 2,369 |
| 2021 | 1 | — | 1 | 2,283 |
| 2022 | 3 | 191 | 0 | 1,574 |
| 2023 | 0 | — | 0 | 1,725 |
| 2024 | 1 | — | 0 | 1,588 |
| 2025 | 1 | — | 0 | 1,469 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K965080 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965080: Anspach Micromax System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965080
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026