510(k) Report

510(k) · Cleared

Cleared

Multimicro Surgical Cautery

K810012510(k) TraditionalCleared Apr 23, 1981108-day reviewClass II21 CFR 886.4115

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

Medical Products Development, Inc. · HQP Unit, Cautery, Thermal, Battery-Powered

Cleared on Apr 23, 1981 after a 108-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 23, 1981
Review
108 days
Class
Class II
Product code
HQP
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K810012Source: 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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  • 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 HQP devices

HQP Unit, Cautery, Thermal, Battery-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQP

1in 2012

2007: 12009: 12012: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQP

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

Recalls per year · HQP

No recall names HQP since 2007.

Adverse event reports per year · HQP

22in 2025

2008: 12009: 22010: 32013: 12016: 22017: 12018: 32019: 22020: 32021: 22022: 72023: 82024: 232025: 22
2007high 23 (2024) · low 0 (2007)2025

MAUDE reports naming product code HQP, 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
20071—00
20080—01
20091—02
20100—03
20110—00
20121—00
20130—01
20140—00
20150—00
20160—02
20170—01
20180—03
20190—02
20200—03
20210—02
20220—07
20230—08
20240—023
20250—022
20260—0—
Cite this page

510(k) Report. “K810012: Multimicro Surgical Cautery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K810012

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