510(k) · Cleared
ClearedKirwan Disposable Battery-Powered Cautery, Model 41-61XX Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kirwan Surgical Products, Inc. · HQP Unit, Cautery, Thermal, Battery-Powered
Cleared on Mar 9, 2007 after a 183-day review. The FDA summary names its predicate without a number.
- Decided
- Mar 9, 2007
- Review
- 183 days
- Class
- Class II
- Product code
- HQP
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | AAXXX Series, Bovie/Aaron Cautery units Named without a submission number | |
| * | — | 844XXXX Series, Medtronic/Solan Cautery units Named without a submission number | |
| * | — | 23X Series, Bovie Medical Corp., Perfectemp Cautery units Named without a submission number |
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 devicesHQP Unit, Cautery, Thermal, Battery-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · HQP
1in 2012
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
MAUDE reports naming product code HQP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 23 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Kirwan battery-powered cautery units are intended for general surgical use to cauterize small blood vessels in order to help reduce blood loss and keep the site clear of excess blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062659: Kirwan Disposable Battery-Powered Cautery, Model 41-61XX Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062659
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026