510(k) · Cleared
ClearedDan Kerrison Rongeurs, Models K1 + Billy 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dannoritzer Medical Instruments · HAE Rongeur, Manual
Cleared on Feb 7, 2003 after a 79-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Feb 7, 2003
- Review
- 79 days
- Class
- Class II
- Product code
- HAE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK023868 Dan Kerrison Rongeurs, Models K1 + Billy 1Dannoritzer Medical Instruments · 2003
- Descendant · cites it directly · 3 of its ownK081651 Instrumed RongeurInstrumed International, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK150468 Laminectomy Rongeurs, Kerrison Rongeurs, IVD RongeursK2 Medical GmbH & Co. KG · 2016
- Descendant · 3 generations on · 0 of its ownK210741 KLS Martin Neuro RongeursKLS-Martin L.P. · 2022
- Descendant · 2 generations on · 0 of its ownK131851 Osteomed Neuro RongeurOsteomed · 2013
Most influential descendants
Showing 4 of 4 · See all- K081651Instrumed RongeurInstrumed International, Inc. · 2008 · cites it directly3descendants
- K150468Laminectomy Rongeurs, Kerrison Rongeurs, IVD RongeursK2 Medical GmbH & Co. KG · 2016 · 2 generations on1descendant
- K210741KLS Martin Neuro RongeursKLS-Martin L.P. · 2022 · 3 generations on0descendants
- K131851Osteomed Neuro RongeurOsteomed · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023868 | Dan Kerrison Rongeurs, Models K1 + Billy 1 | Dannoritzer Medical Instruments | 2003 | — |
| +1 | K081651 | Instrumed Rongeur | Instrumed International, Inc. | 2008 | — |
| +2 | K150468 | Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs | K2 Medical GmbH & Co. KG | 2016 | — |
| +3 | K210741 | KLS Martin Neuro Rongeurs | KLS-Martin L.P. | 2022 | — |
| +2 | K131851 | Osteomed Neuro Rongeur | Osteomed | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HAE? 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 HAE device
- #1 K260446 Tontarra Punches and Rongeursscore 12.6 · 3 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081651 | Instrumed Rongeur | 2008 | 3 |
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, K081651 (Instrumed International, Inc., 2008) has gone furthest, with 3 descendants of its own.
How does its category compare?
All HAE devicesHAE Rongeur, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAE
270in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAE
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HAE
10in 2025
MAUDE reports naming product code HAE, 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 | 2 | — | 0 | 4 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 2 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 31 |
| 2012 | 2 | — | 0 | 47 |
| 2013 | 2 | — | 0 | 20 |
| 2014 | 0 | — | 0 | 15 |
| 2015 | 1 | — | 0 | 25 |
| 2016 | 4 | 270 | 0 | 34 |
| 2017 | 0 | — | 0 | 25 |
| 2018 | 1 | — | 0 | 29 |
| 2019 | 0 | — | 0 | 24 |
| 2020 | 2 | — | 0 | 25 |
| 2021 | 1 | — | 0 | 12 |
| 2022 | 2 | — | 0 | 13 |
| 2023 | 2 | — | 2 | 10 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
DANNORITZER manual rongeurs are designed for cutting or biting bone during surgery involving the skull or spinal column.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023868 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023868: Dan Kerrison Rongeurs, Models K1 + Billy 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023868
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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