510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Aspach 65,000 (Modification)

K955084510(k) TraditionalCleared Jan 17, 199690-day reviewClass I21 CFR 878.4820Recalls 23

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 Jan 17, 1996 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 23 times.

Decided
Jan 17, 1996
Review
90 days
Class
Class I
Product code
HSZ
Recalls
23
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K955084Source: FDA 510(k) database · 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.

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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?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Oct 6, 2016Class IIZ-1979-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-2017-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1965-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1971-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1941-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1973-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1969-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1980-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-2018-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1977-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1974-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1964-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1967-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1970-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1968-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1972-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1975-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1976-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1963-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
May 8, 2014Class IIZ-1983-2014Process controlSeveral attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current Directions for Use (DFU) provided with the device.
Apr 25, 2013Class IIZ-0654-2014Component design/selectionThe 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…
May 6, 2011Class IIZ-0199-2014Labeling Change ControlAnspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and…
May 18, 2007Not classifiedZ-1008-2007Nonconforming Material/ComponentThe white film portion of the sterile pouch may become brittle prior to the expiry date compromising the sterility of the product.

The 5 latest of 23 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

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
  • K954080Sodem High Speed SystemSodem Diffusion SA · 1995
  • K944590Ethicon Drill Bit and Drill GuideETHICON, Inc. · 1995

https://510kreport.com/device/K955084 · printed Nov 6, 2026

Cite this page

510(k) Report. “K955084: Aspach 65,000 (Modification).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955084

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026