510(k) · Cleared
Recalled · Class II · 2024Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)
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 24, 2024 as substantially equivalent to K161000 (Cook Biotech Incorporated, 2016) after a 268-day review. Its family tree reaches back 3 generations to 1998. It has been recalled once.
- Decided
- May 24, 2024
- Review
- 268 days
- Class
- Class II
- Product code
- KHJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K982870 (1998). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK982870 Epifilm Otologic LaminaXomed, Inc. · 1998
- 2 generations backK150594 Biodesign Otologic Repair GraftCook Biotech Incorprated · 2015
- 1 generation backK161000 Biodesign Otologic Repair GraftCook Biotech Incorporated · 2016
- This deviceK232646 Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign…Cook Biotech Incorporated · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K982870 | Epifilm Otologic Lamina | Xomed, Inc. | 1998 | — |
| −2 | K150594 | Biodesign Otologic Repair Graft | Cook Biotech Incorprated | 2015 | — |
| −1 | K161000 | Biodesign Otologic Repair Graft | Cook Biotech Incorporated | 2016 | — |
| 0 (this device) | K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic… | Cook Biotech Incorporated | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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
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 |
|---|---|---|---|
| * | K161000 | Biodesign Otologic Repair GraftSummary page 4…ial) Product Code: KHJ (21 CFR §874.3620) Regulatory Class: Class II III. Predicate Device Biodesign® Otologic Repair Graft (K161000, Cook Biotech Incorporated) IV. Device Description The Biodesign Otologic Butterfly Graft is a self-securing butterfly-style gra… | 2016 |
| † | K150594 | Biodesign Otologic Repair Graft | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 22, 2024 | Class II | Z-0832-2025 | Under Investigation by firm | Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- None of the 4 ancestors has a recall.
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. 2024, 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 Biodesign Otologic Butterfly Graft is intended for use as an implant material to aid in the natural healing process in myringloplasty and tympanoplasty procedures.
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/K232646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232646: Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232646
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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