510(k) Report

510(k) · Cleared

Cleared

Pro-Torq

K000120510(k) SpecialCleared Feb 3, 200016-day reviewClass I21 CFR 872.4200

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

Micro Motors, Inc. · EBW Controller, Foot, Handpiece And Cord

Cleared on Feb 3, 2000 after a 16-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Feb 3, 2000
Review
16 days
Class
Class I
Product code
EBW
Recalls
None
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 K000120Source: 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 EBW? 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 EBW device

  1. #1 K251701 Star E900 Electric Systemscore 12.2 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All EBW devices

EBW Controller, Foot, Handpiece And Cord: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EBW

3in 2025

2009: 52010: 12011: 32012: 12013: 12014: 32015: 12016: 12017: 42018: 12019: 22020: 12021: 22022: 62024: 42025: 32026 (partial year): 3
2007high 6 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBW

220in 2025

2009: 112 days median2011: 226 days median2014: 189 days median2017: 227 days median2022: 479 days median2024: 268 days median2025: 220 days median2026 (partial year): 269 days median
2007high 479 (2022) · low 112 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EBW

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · EBW

13in 2025

2009: 162010: 182011: 12012: 52013: 12014: 42015: 132016: 62017: 132018: 462019: 552020: 712021: 572022: 312023: 172024: 142025: 13
2007high 71 (2020) · low 0 (2007)2025

MAUDE reports naming product code EBW, 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—00
20080—00
20095112016
20101—018
2011322601
20121—05
20131—11
2014318904
20151—013
20161—06
20174227013
20181—046
20192—055
20201—071
20212—057
20226479031
20230—017
20244268014
20253220013
202632690—
Cite this page

510(k) Report. “K000120: Pro-Torq.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000120

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