510(k) · Cleared
ClearedBiprobe (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Jun 20, 1991 after a 10-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jun 20, 1991
- Review
- 10 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK912601 Biprobe (TM)C.R. Bard, Inc. · 1991
- Descendant · cites it directly · 2 of its ownK092571 Gyrus Acmi Biocoag ProbeGyrus Acmi, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK123319 Gyrus Acmi Bicoag Hemostasis ProbeOlympus Surgical Technologies America · 2012 · Recalled
- Descendant · 3 generations on · 0 of its ownK232633 Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe…Boston Scientific · 2023
- Descendant · cites it directly · 0 of its ownK011800 Vanguard Reprocessed Electric Biopsy ForcepsVanguard Medical Concepts, Inc. · 2001
Most influential descendants
Showing 4 of 4 · See all- K092571Gyrus Acmi Biocoag ProbeGyrus Acmi, Inc. · 2010 · cites it directly2descendants
- K123319Gyrus Acmi Bicoag Hemostasis ProbeOlympus Surgical Technologies America · 2012 · 2 generations on1descendant
- K232633Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar…Boston Scientific · 2023 · 3 generations on0descendants
- K011800Vanguard Reprocessed Electric Biopsy ForcepsVanguard Medical Concepts, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K912601 | Biprobe (TM) | C.R. Bard, Inc. | 1991 | — |
| +1 | K092571 | Gyrus Acmi Biocoag Probe | Gyrus Acmi, Inc. | 2010 | — |
| +2 | K123319 | Gyrus Acmi Bicoag Hemostasis Probe | Olympus Surgical Technologies America | 2012 | 5 |
| +3 | K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar… | Boston Scientific | 2023 | — |
| +1 | K011800 | Vanguard Reprocessed Electric Biopsy Forceps | Vanguard Medical Concepts, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2023 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
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?
- Of its descendants, K092571 (Gyrus Acmi, Inc., 2010) has gone furthest, with 2 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/K912601 · printed Nov 6, 2026
Cite this page
510(k) Report. “K912601: Biprobe (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912601
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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