510(k) Report

510(k) · Cleared

Cleared

AC Powered Thermal Cautery Unit

K000893510(k) TraditionalCleared Jun 14, 200086-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

Starion Instruments · HQO Unit, Cautery, Thermal, Ac-Powered

Cleared on Jun 14, 2000 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jun 14, 2000
Review
86 days
Class
Class II
Product code
HQO
Recalls
None
Predicates
0

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

Descendants, by year cleared 2004: 1 descendant cleared2025: 1 descendant cleared2007: 1 descendant cleared200020052010201520202025
  1. This deviceK000893 AC Powered Thermal Cautery UnitStarion Instruments · 2000
  2. Descendant · cites it directly · 2 of its ownK043155 Starion Universal Power Supply (Ups)Starion Instruments · 2004
  3. Descendant · 2 generations on · 0 of its ownK243918 Vasoview Hemopro 3 Power SupplyMaquet Cardiovascular, LLC · 2025
  4. Descendant · 2 generations on · 0 of its ownK070871 Starion Universal Power SupplyStarion Instruments · 2007

Most influential descendants

Showing 3 of 3 · See all
  • K043155Starion Universal Power Supply (Ups)Starion Instruments · 2004 · cites it directly2descendants
  • K243918Vasoview Hemopro 3 Power SupplyMaquet Cardiovascular, LLC · 2025 · 2 generations on0descendants
  • K070871Starion Universal Power SupplyStarion Instruments · 2007 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000893AC Powered Thermal Cautery UnitStarion Instruments2000—
+1K043155Starion Universal Power Supply (Ups)Starion Instruments2004—
+2K243918Vasoview Hemopro 3 Power SupplyMaquet Cardiovascular, LLC2025—
+2K070871Starion Universal Power SupplyStarion Instruments2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200710
202510
FIG. 1 — Lineage of K000893, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 HQO? 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? (3)

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

NumberDeviceApplicantDecidedDescendants
K043155Starion Universal Power Supply (Ups)Starion Instruments20042

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, K043155 (Starion Instruments, 2004) has gone furthest, with 2 descendants of its own.

How does its category compare?

All HQO devices

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

FDA decisions per year · HQO

1in 2007

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

2026 to Oct 25, outlined.

Median 510(k) review, days · HQO

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

Recalls per year · HQO

No recall names HQO since 2007.

Adverse event reports per year · HQO

101in 2025

2010: 132011: 302012: 292013: 402014: 552015: 422016: 562018: 172019: 732020: 442021: 562022: 532023: 482024: 662025: 101
2007high 101 (2025) · low 0 (2007)2025

MAUDE reports naming product code HQO, 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—00
20090—00
20100—013
20110—030
20120—029
20130—040
20140—055
20150—042
20160—056
20170—00
20180—017
20190—073
20200—044
20210—056
20220—053
20230—048
20240—066
20250—0101
20260—0—

More from Starion Instruments

13 FDA decisions under this applicant name. See the company

  • K070871Starion Universal Power SupplyStarion Instruments · 2007
  • K062257Starion Instruments Thermal Litigating ShearsStarion Instruments · 20063 recalls
  • K050308Thermal Cautery ProbeStarion Instruments · 2005
  • K043155Starion Universal Power Supply (Ups)Starion Instruments · 2004
  • K002547Starion Instruments Power Point Cautery Grasper/DissectorStarion Instruments · 2000

Recent decisions in HQO

The HQO category page

  • K070871Starion Universal Power SupplyStarion Instruments · 2007
  • K043155Starion Universal Power Supply (Ups)Starion Instruments · 2004
  • K002341Thermal Cautery Unit, Model 150Geiger Medical Technologies, Inc. · 2000
  • K971538Mentor Gemini Hemostatic EraserMentor Ophthalmics, Inc. · 1997
  • K962135D.O.R.C. Microdiathermy SystemDutch Ophthalmic USA, Inc. · 1996

https://510kreport.com/device/K000893 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000893: AC Powered Thermal Cautery Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000893

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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