510(k) Report

510(k) · Cleared

Cleared

Hall Oscillator

K832187510(k) TraditionalCleared Aug 12, 198337-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 Aug 12, 1983 after a 37-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.

Decided
Aug 12, 1983
Review
37 days
Class
Class I
Product code
GET
Recalls
None
Predicates
0

7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2006: 1 descendant cleared2022: 2 descendants cleared2017: 1 descendant cleared2021: 1 descendant cleared2007: 1 descendant cleared19801990200020102020
  1. This deviceK832187 Hall OscillatorAmsco Co. · 1983
  2. Descendant · cites it directly · 6 of its ownK032607 Powerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185Linvatec Corp. · 2003
  3. Descendant · 2 generations on · 5 of its ownK062842 Twist DrillWalter Lorenz Surgical, Inc. · 2006 · Recalled
  4. Descendant · 3 generations on · 1 of its ownK213072 2.1 x 255mm Drill, 22mm StopBiomet Micofixation · 2022
  5. Descendant · 4 generations on · 0 of its ownK223199 2.1 x 255mm Drill, 22mm StopBiomet Microfixation · 2022
  6. Descendant · 3 generations on · 0 of its ownK213208 Twist DrillsBiomet Microfixation · 2021

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2003: 12006: 12007: 12017: 12021: 12022: 2
2003high 2 (2022) · low 0 (2004)2026

Most influential descendants

Showing 5 of 7 · See all
  • K032607Powerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185Linvatec Corp. · 2003 · cites it directly6descendants
  • K062842Twist DrillWalter Lorenz Surgical, Inc. · 2006 · 2 generations on5descendants
  • K2130722.1 x 255mm Drill, 22mm StopBiomet Micofixation · 2022 · 3 generations on1descendant
  • K2231992.1 x 255mm Drill, 22mm StopBiomet Microfixation · 2022 · 4 generations on0descendants
  • K213208Twist DrillsBiomet Microfixation · 2021 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K832187Hall OscillatorAmsco Co.1983—
+1K032607Powerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185Linvatec Corp.2003—
+2K062842Twist DrillWalter Lorenz Surgical, Inc.20061
+3K2130722.1 x 255mm Drill, 22mm StopBiomet Micofixation2022—
+4K2231992.1 x 255mm Drill, 22mm StopBiomet Microfixation2022—
+3K213208Twist DrillsBiomet Microfixation2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200610
200710
201710
202110
202220
FIG. 1 — Lineage of K832187, 1983–2022Source: 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 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? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032607Powerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185Linvatec Corp.20036

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.

What does this lineage say?

  • Of its descendants, K032607 (Linvatec Corp., 2003) has gone furthest, with 6 descendants of its own.

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—
Cite this page

510(k) Report. “K832187: Hall Oscillator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K832187

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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