510(k) · Cleared
ClearedInstrumed Rongeur
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumed International, Inc. · HAE Rongeur, Manual
Cleared on Aug 8, 2008 as substantially equivalent to K062711 (Baxano, Inc., 2007) and 2 other predicates after a 57-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- Aug 8, 2008
- Review
- 57 days
- Class
- Class II
- Product code
- HAE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K943635 (1994). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK943635 Ultra-Line RongeurV. Mueller Neuro/Spine · 1994
- This deviceK081651 Instrumed RongeurInstrumed International, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK150468 Laminectomy Rongeurs, Kerrison Rongeurs, IVD RongeursK2 Medical GmbH & Co. KG · 2016
- Descendant · 2 generations on · 0 of its ownK210741 KLS Martin Neuro RongeursKLS-Martin L.P. · 2022
- Descendant · cites it directly · 0 of its ownK131851 Osteomed Neuro RongeurOsteomed · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943635 | Ultra-Line Rongeur | V. Mueller Neuro/Spine | 1994 | — |
| 0 (this device) | K081651 | Instrumed Rongeur | Instrumed International, Inc. | 2008 | — |
| +1 | K150468 | Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs | K2 Medical GmbH & Co. KG | 2016 | — |
| +2 | K210741 | KLS Martin Neuro Rongeurs | KLS-Martin L.P. | 2022 | — |
| +1 | K131851 | Osteomed Neuro Rongeur | Osteomed | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 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 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? (4)
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 |
|---|---|---|---|
| * | K062711 | Ultra Low Profile RongeurSummary page 1…manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column. Substantial Equivalence Claim: K062711; Baxano; Ultra Low profile Rongeur K023868; Dannoritzer Medical Instruments; Dan K… | 2007 |
| * | K023868 | Dan Kerrison Rongeurs, Models K1 + Billy 1Summary page 1…e during surgery involving the skull or spinal column. Substantial Equivalence Claim: K062711; Baxano; Ultra Low profile Rongeur K023868; Dannoritzer Medical Instruments; Dan Kerrison Rongeurs, Models K1 & BILLY 1 K943635; CARDINAL HEALTH(V.MUELLE… | 2003 |
| * | K943635 | Ultra-Line RongeurSummary page 1…11; Baxano; Ultra Low profile Rongeur K023868; Dannoritzer Medical Instruments; Dan Kerrison Rongeurs, Models K1 & BILLY 1 K943635; CARDINAL HEALTH(V.MUELLER) Rongeurs K-MEDIC/TELEFLEX; IVD Rongeurs and Spinal Punches… | 1994 |
| * | — | K-MEDIC/TELEFLEX; IVD Rongeurs and Spinal Punches Named without a submission number |
What descends from it? (3)
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 HAE devicesHAE Rongeur, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
The intended use of Instrumed Rongeur is to access, cut and bite soft tissue and bone during surgery involving the spinal column.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081651: Instrumed Rongeur.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081651
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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