510(k) Report

510(k) · Cleared

Recalled · 2006

Anspach 65,000

K831756510(k) TraditionalCleared Sep 29, 1983120-day reviewClass I21 CFR 878.4820Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

The Anspach Effort, Inc. · HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment

Cleared on Sep 29, 1983 after a 120-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled once.

Decided
Sep 29, 1983
Review
120 days
Class
Class I
Product code
HSZ
Recalls
1
Predicates
0

4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared1997: 1 descendant cleared2006: 1 descendant cleared1999: 1 descendant cleared19801990200020102020
  1. This deviceK831756 Anspach 65,000The Anspach Effort, Inc. · 1983
  2. Descendant · cites it directly · 1 of its ownK022907 Anspach Powered Kerrison System (PKS)The Anspach Effort, Inc. · 2002
  3. Descendant · cites it directly · 1 of its ownK954717 Sodem High Speed System for Neurosurgery & Median SternotomySodem Diffusion SA · 1997
  4. Descendant · 2 generations on · 0 of its ownK062413 Aesculap Pneumatic KerrisonAesculap, Inc. · 2006
  5. Descendant · 2 generations on · 0 of its ownK993851 Sodem Perforator DriveSodemsystems · 1999

Most influential descendants

Showing 4 of 4 · See all
  • K022907Anspach Powered Kerrison System (PKS)The Anspach Effort, Inc. · 2002 · cites it directly1descendant
  • K954717Sodem High Speed System for Neurosurgery & Median SternotomySodem Diffusion SA · 1997 · cites it directly1descendant
  • K062413Aesculap Pneumatic KerrisonAesculap, Inc. · 2006 · 2 generations on0descendants
  • K993851Sodem Perforator DriveSodemsystems · 1999 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K831756Anspach 65,000The Anspach Effort, Inc.1983—
+1K022907Anspach Powered Kerrison System (PKS)The Anspach Effort, Inc.2002—
+1K954717Sodem High Speed System for Neurosurgery & Median SternotomySodem Diffusion SA1997—
+2K062413Aesculap Pneumatic KerrisonAesculap, Inc.2006—
+2K993851Sodem Perforator DriveSodemsystems1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200210
200610
FIG. 1 — Lineage of K831756, 1983–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 HSZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K022907Anspach Powered Kerrison System (PKS)The Anspach Effort, Inc.20021
K954717Sodem High Speed System for Neurosurgery & Median SternotomySodem Diffusion SA19971

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 18, 2006Not classifiedZ-1039-2008Labeling False and MisleadingIncorrect 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…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K022907 (The Anspach Effort, Inc., 2002) has gone furthest, with 1 descendant of its own.

How does its category compare?

All HSZ devices

HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HSZ

FDA has decided no HSZ device since 2007.

Median 510(k) review, days · HSZ

Too few HSZ 510(k)s in any year since 2007 to give a median.

Recalls per year · HSZ

1in 2013

2011: 12013: 1
2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HSZ

4in 2025

2007: 1112008: 132009: 142010: 112011: 32012: 272013: 4112014: 182015: 202016: 272017: 242018: 132019: 52020: 132021: 272022: 352023: 392024: 72025: 4
2007high 411 (2013) · low 3 (2011)2025

MAUDE reports naming product code HSZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—0111
20080—013
20090—014
20100—011
20110—13
20120—027
20130—1411
20140—018
20150—020
20160—027
20170—024
20180—013
20190—05
20200—013
20210—027
20220—035
20230—039
20240—07
20250—04
20260—0—

More from The Anspach Effort, Inc.

60 FDA decisions under this applicant name. See the company

  • K220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)The Anspach Effort, Inc. · 2022
  • K183545Anspach Helix Dissection ToolsThe Anspach Effort, Inc. · 2019
  • K180063OCM-G1 AttachmentThe Anspach Effort, Inc. · 2018
  • K133604Anspach EG1 High Speed System, G1 AttachmentsThe Anspach Effort, Inc. · 201411 recalls
  • K131053Anspach Xmax, EMAX2 and EMAX2 Plus System with Otologic Attachment SystemThe Anspach Effort, Inc. · 20133 recalls

Recent decisions in HSZ

The HSZ category page

  • K991588Ems Swiss Orthoclast(Ems Sa) Electro Medical Systems · 1999
  • K972860Curvtek TSR SystemBiolectron, Inc. · 1997
  • K970345Alignment InstrumentRichard Wolf Medical Instruments Corp. · 1997
  • K955084Aspach 65,000 (Modification)The Anspach Effort, Inc. · 199623 recalls
  • K954080Sodem High Speed SystemSodem Diffusion SA · 1995

https://510kreport.com/device/K831756 · printed Nov 3, 2026

Cite this page

510(k) Report. “K831756: Anspach 65,000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K831756

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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