510(k) · Cleared
ClearedBiodesign Otologic Repair Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Biotech Incorporated · KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Cleared on May 11, 2016 as substantially equivalent to K150594 (Cook Biotech Incorprated, 2015) after a 30-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- May 11, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- KHJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K982870 (1998). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK982870 Epifilm Otologic LaminaXomed, Inc. · 1998
- 1 generation backK150594 Biodesign Otologic Repair GraftCook Biotech Incorprated · 2015
- This deviceK161000 Biodesign Otologic Repair GraftCook Biotech Incorporated · 2016
- Descendant · cites it directly · 0 of its ownK232646 Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign…Cook Biotech Incorporated · 2024 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly…Cook Biotech Incorporated · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K982870 | Epifilm Otologic Lamina | Xomed, Inc. | 1998 | — |
| −1 | K150594 | Biodesign Otologic Repair Graft | Cook Biotech Incorprated | 2015 | — |
| 0 (this device) | K161000 | Biodesign Otologic Repair Graft | Cook Biotech Incorporated | 2016 | — |
| +1 | K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic… | Cook Biotech Incorporated | 2024 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 KHJ? 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 KHJ device
- #1 K260266 Tympendi™ (810)score 12.2 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K150594 | Biodesign Otologic Repair GraftSummary page 4…been established under Section 514 of the Food, Drug and Cosmetic act apply to this device. Predicate Device: The predicate device is Biodesign® Otologic Repair Graft (K150594), cleared September 16, 2015. Intended Use: The Cook® Biodesign® Otologic Repair Graft is intended for use as an implant materia… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly… | 2024 | 0 |
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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 16.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K232646 (Cook Biotech Incorporated, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KHJ devicesKHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · KHJ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KHJ
46in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KHJ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHJ
1in 2025
MAUDE reports naming product code KHJ, 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 | — | 0 | 0 |
| 2008 | 3 | 46 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 1 | — | 1 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 1 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Cook® Biodesign® Otologic Repair Graft is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures, including but not limited to myringoplasty and tympanoplasty. The device is supplied sterile and is intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161000 · printed Nov 4, 2026
Cite this page
510(k) Report. “K161000: Biodesign Otologic Repair Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K161000
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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