510(k) Report

510(k) · Cleared

Cleared

Thermal Cautery Probe

K050308510(k) SpecialCleared Feb 25, 200517-day reviewClass II21 CFR 886.4100

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

Starion Instruments · HQR Apparatus, Cautery, Radiofrequency, Ac-Powered

Cleared on Feb 25, 2005 as substantially equivalent to K000296 (Starion Instruments, 2000) after a 17-day review. Its family tree reaches back 1 generation to 2000.

Decided
Feb 25, 2005
Review
17 days
Class
Class II
Product code
HQR
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K000296 (2000). No later device cites it as a predicate yet.

K000296 · Starion Cautery Hook · Starion Instruments · 20002000200220042006
K000296 · Starion Cautery Hook · Starion Instruments · 20000
  1. Root · 1 generation backK000296 Starion Cautery HookStarion Instruments · 2000
  2. This deviceK050308 Thermal Cautery ProbeStarion Instruments · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K000296Starion Cautery HookStarion Instruments2000—
0 (this device)K050308Thermal Cautery ProbeStarion Instruments2005—
FIG. 1 — Lineage of K050308, 2000–2005Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HQR? 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K000296Starion Cautery Hook
Summary page 1
…source, and principles of operation to the Starion Instruments Thermal Cautery Hook, a legally marketable predicate device which has been granted marketing clearance via K000296. The Station Instruments Thermal Cautery Probe allows the surgeon to position the probe in the region of tissue to be cau…
Starion Instruments2000—

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.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All HQR devices

HQR Apparatus, Cautery, Radiofrequency, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQR

FDA has decided no HQR device since 2007.

Median 510(k) review, days · HQR

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

Recalls per year · HQR

No recall names HQR since 2007.

Adverse event reports per year · HQR

3in 2024

2008: 12010: 12011: 52013: 12014: 12015: 42016: 12017: 12018: 32020: 12021: 22022: 12024: 3
2007high 5 (2011) · low 0 (2007)2025

MAUDE reports naming product code HQR, 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—01
20090—00
20100—01
20110—05
20120—00
20130—01
20140—01
20150—04
20160—01
20170—01
20180—03
20190—00
20200—01
20210—02
20220—01
20230—00
20240—03
20250—00
20260—0—

What is it indicated for?

For the simultaneous cutting and cauterization of soft tissue during surgery.

Indications for use as stated in the FDA summary.

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
  • K043155Starion Universal Power Supply (Ups)Starion Instruments · 2004
  • K002547Starion Instruments Power Point Cautery Grasper/DissectorStarion Instruments · 2000
  • K001262Thermal Cautery ForcepsStarion Instruments · 2000

Recent decisions in HQR

The HQR category page

  • K990064DI-Rhex Ophthalmic Diathermy SystemOphthalmic Technologies, Inc. · 1999
  • K980522Refractec MCS-100Refractec, Inc. · 1998
  • K972749Pao Bipolar Coaxial Coagulator (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)C.M. Chance, Ltd. · 1998
  • K952151Storz Ophthalmic Bipolar Cautery Instruments (D8200, D8201, D8203) and Bipolar Cords (D8202, D8204)Storz · 1996
  • K955158SurgitronEllman Intl., Inc. · 1996

https://510kreport.com/device/K050308 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050308: Thermal Cautery Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050308

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026