510(k) · Cleared
ClearedThermal Cautery Device, Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Starion Instruments · HQP Unit, Cautery, Thermal, Battery-Powered
Cleared on Jun 3, 1999 as substantially equivalent to K902307 (Hemostatic Surgery Corp., 1990) after a 90-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it.
- Decided
- Jun 3, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- HQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902307 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
- This deviceK990728 Thermal Cautery Device, ForcepsStarion Instruments · 1999
- Descendant · cites it directly · 0 of its ownK994019 Cautery Grasper/DissectorStarion Instruments · 2000
- Descendant · cites it directly · 0 of its ownK992460 Cautery Clamp and Battery Pack Power SupplyStarion Instruments · 1999
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | 1990 | 2 |
| 0 (this device) | K990728 | Thermal Cautery Device, Forceps | Starion Instruments | 1999 | — |
| +1 | K994019 | Cautery Grasper/Dissector | Starion Instruments | 2000 | — |
| +1 | K992460 | Cautery Clamp and Battery Pack Power Supply | Starion Instruments | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K902307 | Shaw II Hemostatic Surgery SystemSummary page 1…ntends to introduce into commercial distribution the Cautery Forceps and Battery Pack Power Supply. The equivalent predicate devices are the Hemostatic Surgical System (#K 902307) by Hemostatic Surgery Corporation and the Accu-Temp disposable hot wire surgical cautery device (preamendment) by Concept, Inc.… | 1990 |
| * | — | Accu-Temp disposable hot wire surgical cautery device Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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.
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?
Simultaneous cutting and cauterization of soft tissue during surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990728 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990728: Thermal Cautery Device, Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990728
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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