510(k) · Cleared
ClearedHpu Heat Probe Automated Electrocautery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Corp. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on May 22, 1985 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.
- Decided
- May 22, 1985
- Review
- 64 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 1 citing it directly.
- This deviceK851096 Hpu Heat Probe Automated Electrocautery SystemOlympus Corp. · 1985
- Descendant · cites it directly · 15 of its ownK982289 Heat Probe Unit Hpu-20, Heat Probe CD-110##/120##Olympus America, Inc. · 1998
- Descendant · 2 generations on · 14 of its ownK093008 Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated · 2010
- Descendant · 3 generations on · 4 of its ownK183595 Aqua Medical RF Vapor SystemAqua Medical, Inc. · 2019
- Descendant · 3 generations on · 4 of its ownK112454 HALO60 Ablation CatheterBarrx Medical, Inc. · 2012
- Descendant · 4 generations on · 3 of its ownK211282 Aqua Medical RF Vapor SystemAqua Medical, Inc. · 2021
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K982289Heat Probe Unit Hpu-20, Heat Probe CD-110##/120##Olympus America, Inc. · 1998 · cites it directly15descendants
- K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated · 2010 · 2 generations on14descendants
- K183595Aqua Medical RF Vapor SystemAqua Medical, Inc. · 2019 · 3 generations on4descendants
- K112454HALO60 Ablation CatheterBarrx Medical, Inc. · 2012 · 3 generations on4descendants
- K211282Aqua Medical RF Vapor SystemAqua Medical, Inc. · 2021 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K851096 | Hpu Heat Probe Automated Electrocautery System | Olympus Corp. | 1985 | — |
| +1 | K982289 | Heat Probe Unit Hpu-20, Heat Probe CD-110##/120## | Olympus America, Inc. | 1998 | — |
| +2 | K093008 | Halo Ablation Catheter, Model 90-9100 | Barrx Medical, Incorporated | 2010 | — |
| +3 | K183595 | Aqua Medical RF Vapor System | Aqua Medical, Inc. | 2019 | — |
| +3 | K112454 | HALO60 Ablation Catheter | Barrx Medical, Inc. | 2012 | — |
| +4 | K211282 | Aqua Medical RF Vapor System | Aqua Medical, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
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 KNS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KNS device
- #1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982289 | Heat Probe Unit Hpu-20, Heat Probe CD-110##/120## | 1998 | 15 |
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, K982289 (Olympus America, Inc., 1998) has gone furthest, with 15 descendants of its own.
How does its category compare?
All KNS devicesKNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNS
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNS
14in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNS
1,504in 2025
MAUDE reports naming product code KNS, 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 | — | 3 | 164 |
| 2008 | 3 | 61 | 5 | 587 |
| 2009 | 3 | 212 | 2 | 1,027 |
| 2010 | 4 | 168 | 0 | 908 |
| 2011 | 1 | — | 2 | 860 |
| 2012 | 2 | — | 0 | 848 |
| 2013 | 2 | — | 0 | 449 |
| 2014 | 1 | — | 0 | 405 |
| 2015 | 3 | 252 | 0 | 406 |
| 2016 | 3 | 30 | 6 | 457 |
| 2017 | 3 | 48 | 1 | 446 |
| 2018 | 5 | 62 | 0 | 563 |
| 2019 | 7 | 66 | 0 | 668 |
| 2020 | 4 | 212 | 0 | 906 |
| 2021 | 4 | 139 | 41 | 814 |
| 2022 | 3 | 182 | 0 | 913 |
| 2023 | 9 | 83 | 0 | 976 |
| 2024 | 3 | 198 | 14 | 1,533 |
| 2025 | 11 | 171 | 0 | 1,504 |
| 2026 | 2 | — | 4 | — |
https://510kreport.com/device/K851096 · printed Nov 5, 2026
Cite this page
510(k) Report. “K851096: Hpu Heat Probe Automated Electrocautery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K851096
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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