510(k) Report

510(k) · Cleared

Cleared

Cautery; Low Temperature (Fineadjustable Fine Tip, Elongated Fine Tip, Micro Fine Tip)

K121441510(k) TraditionalCleared Jul 20, 201266-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

Bovie Medical Corporation · HQP Unit, Cautery, Thermal, Battery-Powered

Cleared on Jul 20, 2012 as substantially equivalent to K945757 (Aaron Medical Industries, 1995) and 10 other predicates after a 66-day review. Its family tree reaches back 1 generation to 1981. 2 later devices descend from it.

Decided
Jul 20, 2012
Review
66 days
Class
Class II
Product code
HQP
Recalls
None
Predicates
11

Its longest line of descent runs back 1 generation to K810017 (1981). 11 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 9 other ancestors1981: 1 other ancestor2024: 1 descendant cleared2026: 1 descendant clearedK810017 · Microsurg Cautery · Medical Products Development, Inc. · 198119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 10 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K810017 · Microsurg Cautery · Medical Products Development, Inc. · 19810
  1. Root · 1 generation backK810017 Microsurg CauteryMedical Products Development, Inc. · 1981
  2. This deviceK121441 Cautery; Low Temperature (Fineadjustable Fine Tip, Elongated Fine…Bovie Medical Corporation · 2012
  3. Descendant · cites it directly · 1 of its ownK232805 Kronos Electrocautery DeviceSingle Pass, Inc. · 2024
  4. Descendant · 2 generations on · 0 of its ownK260287 SP Electrocautery Device (SP20)Single Pass, Inc. · 2026

Most influential descendants

Showing 2 of 2 · See all
  • K232805Kronos Electrocautery DeviceSingle Pass, Inc. · 2024 · cites it directly1descendant
  • K260287SP Electrocautery Device (SP20)Single Pass, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K810017Microsurg CauteryMedical Products Development, Inc.1981—
0 (this device)K121441Cautery; Low Temperature (Fineadjustable Fine Tip, Elongated Fine Tip, Micro…Bovie Medical Corporation2012—
+1K232805Kronos Electrocautery DeviceSingle Pass, Inc.2024—
+2K260287SP Electrocautery Device (SP20)Single Pass, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
199590

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
202610
FIG. 1 — Lineage of K121441, 1981–2026Source: 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 HQP? 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
Get a 510(k) Report

What was it cleared against? (11)

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
*K945757High Temperature Cautery Fine Adjustable
Summary page 1
…Legally Marketed Predicate Device(s): Various Hand Held, Battery Operated Cautery Devices (K945757, K945765, K945492, K945764, K810909, K8 10017, K945760, K945759, K945493, K945762,…
Aaron Medical Industries1995—
*K945765High Temperature Cautery
Summary page 1
…ally Marketed Predicate Device(s): Various Hand Held, Battery Operated Cautery Devices (K945757, K945765, K945492, K945764, K810909, K8 10017, K945760, K945759, K945493, K945762,…
Aaron Medical Industries19951
*K945492High Temperature Cautery
Summary page 1
…eted Predicate Device(s): Various Hand Held, Battery Operated Cautery Devices (K945757, K945765, K945492, K945764, K810909, K8 10017, K945760, K945759, K945493, K945762,…
Aaron Medical Industries1995—
*K945764High Temperature Cautery Elongated Fine Tip
Summary page 1
…Predicate Device(s): Various Hand Held, Battery Operated Cautery Devices (K945757, K945765, K945492, K945764, K810909, K8 10017, K945760, K945759, K945493, K945762,…
Aaron Medical Industries1995—
*K810909Micro Cautery
Summary page 1
…Predicate Device(s): Various Hand Held, Battery Operated Cautery Devices (K945757, K945765, K945492, K945764, K810909, K8 10017, K945760, K945759, K945493, K945762,…
Key Medical, Inc.1981—
*K810017Microsurg Cautery
Summary page 1
…tery Operated Cautery Devices (K945757, K945765, K945492, K945764, K810909, K8 10017, K945760, K945759, K945493, K945762, K945763) 5115 Ulmertori Road - Clearwater…
Medical Products Development, Inc.1981—
*K945760High Temperature Cautery
Summary page 1
…ted Cautery Devices (K945757, K945765, K945492, K945764, K810909, K8 10017, K945760, K945759, K945493, K945762, K945763) 5115 Ulmertori Road - Clearwater, FL .337…
Aaron Medical Industries1995—
*K945759High Temperature Cautery 5 Loop
Summary page 1
…ry Devices (K945757, K945765, K945492, K945764, K810909, K8 10017, K945760, K945759, K945493, K945762, K945763) 5115 Ulmertori Road - Clearwater, FL .33760-4004…
Aaron Medical Industries1995—
*K945493Ophthalmic Cautery
Summary page 1
…s (K945757, K945765, K945492, K945764, K810909, K8 10017, K945760, K945759, K945493, K945762, K945763) 5115 Ulmertori Road - Clearwater, FL .33760-4004 Phone: 7…
Aaron Medical Industries1995—
*K945762Low Temperature Cautery Fine Tip, Adjustable
Summary page 1
…(K945757, K945765, K945492, K945764, K810909, K8 10017, K945760, K945759, K945493, K945762, K945763) 5115 Ulmertori Road - Clearwater, FL .33760-4004 Phone: 7??7-B255…
Aaron Medical Industries1995—
*K945763Low Temperature Cautery Elongated Fine Tip
Summary page 1
…5, K945492, K945764, K810909, K8 10017, K945760, K945759, K945493, K945762, K945763) 5115 Ulmertori Road - Clearwater, FL .33760-4004 Phone: 7??7-B255 Fax: 727-547-9144'- www.boviemed.com === Page 2…
Aaron Medical Industries1995—

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K232805Kronos Electrocautery DeviceSingle Pass, Inc.20241

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?

  • 1 of the 11 ancestors has a recall of any class.
  • Of its descendants, K232805 (Single Pass, Inc., 2024) has gone furthest, with 1 descendant of its own.

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. 2012, this device’s year, is highlighted.

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—

What is it indicated for?

Bovie Cautery Devices are used for stopping small bleeders in hemostasis and other similar uses.

Indications for use as stated in the FDA summary.

More from Bovie Medical Corporation

14 FDA decisions under this applicant name. See the company

  • K183610Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise…Bovie Medical Corporation · 20191 recall
  • K170777Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation · 2017
  • K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical GeneratorBovie Medical Corporation · 20176 recalls
  • K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar…Bovie Medical Corporation · 20163 recalls
  • K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942…Bovie Medical Corporation · 2016

Recent decisions in HQP

The HQP category page

  • K083428F7244, F7255, F7266, F7277, F7288, F7233, F7234 Series of Battery-Powered CauteryFiab Spa · 2009
  • K062659Kirwan Disposable Battery-Powered Cautery, Model 41-61XX SeriesKirwan Surgical Products, Inc. · 2007
  • K023506Surgical Medical Device CauteryModern Medical Equipment Mfg., Ltd. · 2004
  • K002547Starion Instruments Power Point Cautery Grasper/DissectorStarion Instruments · 2000
  • K994019Cautery Grasper/DissectorStarion Instruments · 2000

https://510kreport.com/device/K121441 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121441: Cautery; Low Temperature (Fineadjustable Fine Tip, Elongated Fine Tip, Micro Fine Tip).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121441

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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