510(k) · Cleared
ClearedHeat Probe Unit Hpu-20, Heat Probe CD-110##/120##
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Aug 19, 1998 as substantially equivalent to K851096 (Olympus Corp., 1985) after a 50-day review. Its family tree reaches back 1 generation to 1985. 15 later devices descend from it.
- Decided
- Aug 19, 1998
- Review
- 50 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K851096 (1985). 15 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK851096 Hpu Heat Probe Automated Electrocautery SystemOlympus Corp. · 1985
- This deviceK982289 Heat Probe Unit Hpu-20, Heat Probe CD-110##/120##Olympus America, Inc. · 1998
- Descendant · cites it directly · 14 of its ownK093008 Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated · 2010
- Descendant · 2 generations on · 4 of its ownK183595 Aqua Medical RF Vapor SystemAqua Medical, Inc. · 2019
- Descendant · 2 generations on · 4 of its ownK112454 HALO60 Ablation CatheterBarrx Medical, Inc. · 2012
- Descendant · 3 generations on · 3 of its ownK211282 Aqua Medical RF Vapor SystemAqua Medical, Inc. · 2021
- Descendant · 3 generations on · 2 of its ownK213627 RF Vapor SystemAqua Medical, Inc. · 2021
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated · 2010 · cites it directly14descendants
- K183595Aqua Medical RF Vapor SystemAqua Medical, Inc. · 2019 · 2 generations on4descendants
- K112454HALO60 Ablation CatheterBarrx Medical, Inc. · 2012 · 2 generations on4descendants
- K211282Aqua Medical RF Vapor SystemAqua Medical, Inc. · 2021 · 3 generations on3descendants
- K213627RF Vapor SystemAqua Medical, Inc. · 2021 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851096 | Hpu Heat Probe Automated Electrocautery System | Olympus Corp. | 1985 | — |
| 0 (this device) | K982289 | Heat Probe Unit Hpu-20, Heat Probe CD-110##/120## | Olympus America, Inc. | 1998 | — |
| +1 | K093008 | Halo Ablation Catheter, Model 90-9100 | Barrx Medical, Incorporated | 2010 | — |
| +2 | K183595 | Aqua Medical RF Vapor System | Aqua Medical, Inc. | 2019 | — |
| +2 | K112454 | HALO60 Ablation Catheter | Barrx Medical, Inc. | 2012 | — |
| +3 | K211282 | Aqua Medical RF Vapor System | Aqua Medical, Inc. | 2021 | — |
| +3 | K213627 | RF Vapor System | Aqua Medical, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K851096 | Hpu Heat Probe Automated Electrocautery SystemSummary page 1…tch for model HPU-20 MAJ-528 Heat Probe CD-110##/120## Common Name: Classification Name: Predicate Device: Heat Probe Unit No Classified name HPU Heat Probe Olympus K851096 T ey A A AV 0% 9940 KAFLE @ oos § & of 3 D. Description of the Device The Heat Probe Unit HPU-20 and its assoc… | 1985 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093008 | Halo Ablation Catheter, Model 90-9100 | 2010 | 14 |
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.
- Of its descendants, K093008 (Barrx Medical, Incorporated, 2010) has gone furthest, with 14 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 | — |
What is it indicated for?
The Olympus Heat Probe Unit HPU-20 has been designed for thermal cautery with the Olympus Heat Probes.
The Olympus Heat Probe has been specifically designed to thermo-cauterize bleeding sites within the gastrointestinal tract under endoscopic observation.
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/K982289 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982289: Heat Probe Unit Hpu-20, Heat Probe CD-110##/120##.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982289
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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