510(k) Report

510(k) · Cleared

Cleared

Hall Osteon

K833187510(k) TraditionalCleared Oct 31, 198342-day reviewClass I21 CFR 878.4820

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

Amsco Co. · GET Motor, Surgical Instrument, Pneumatic Powered

Cleared on Oct 31, 1983 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 31, 1983
Review
42 days
Class
Class I
Product code
GET
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K833187Source: 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.

Planning a device in GET? 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?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All GET devices

GET Motor, Surgical Instrument, Pneumatic Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GET

FDA has decided no GET device since 2007.

Median 510(k) review, days · GET

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

Recalls per year · GET

1in 2013

2008: 472013: 1
2007high 47 (2008) · low 0 (2007)2026

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

Adverse event reports per year · GET

8in 2025

2007: 332008: 82009: 112010: 352011: 2802012: 482013: 342014: 262015: 432016: 292017: 452018: 462019: 152020: 152021: 92022: 132023: 62024: 192025: 8
2007high 280 (2011) · low 6 (2023)2025

MAUDE reports naming product code GET, 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—033
20080—478
20090—011
20100—035
20110—0280
20120—048
20130—134
20140—026
20150—043
20160—029
20170—045
20180—046
20190—015
20200—015
20210—09
20220—013
20230—06
20240—019
20250—08
20260—0—

More from Amsco Co.

19 FDA decisions under this applicant name. See the company

  • K912471Eagle 3000 SDSAmsco Co. · 1992
  • K854922Amsco Polaris SLAmsco Co. · 1986
  • K832945Eagle 2000 Sterilizer Series Gas/AeraAmsco Co. · 1983
  • K832188Hall ReciprocatorAmsco Co. · 1983
  • K831086Ceiling Mounted SupportAmsco Co. · 1983

Recent decisions in GET

The GET category page

  • K960473Aesculap Power System HandpieceAesculap, Inc. · 1996
  • K955174Sodem High Speed System for Neurosurgery & Median StyernotomySodem Diffusion SA · 1996
  • K942987Nucleotome L KitSurgical Dynamics, Inc. · 1995
  • K954076Midas Rex Drill Attachments & Twist DrillsMidas Rex Pneumatic Tools, Inc. · 1995
  • K953433Midas Rex Telescoping SystemMidas Rex Pneumatic Tools, Inc. · 19952 recalls

https://510kreport.com/device/K833187 · printed Nov 4, 2026

Cite this page

510(k) Report. “K833187: Hall Osteon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K833187

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