510(k) · Cleared
ClearedTympendi™ (810)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grace Medical, Inc. · KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Cleared on Aug 18, 2026 as substantially equivalent to K033796 (Heinz Kurz GmbH Medizintechnik, 2004) after a 202-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Aug 18, 2026
- Review
- 202 days
- Class
- Class II
- Product code
- KHJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K974653 (1998). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974653 | Silicone Elastomer Sheeting | Specialty Surgical Products, Inc. | 1998 | — |
| −1 | K033796 | Kurz Silicone Strips, Models SF-1, SF-1W, SF-1 BS | Heinz Kurz GmbH Medizintechnik | 2004 | — |
| 0 (this device) | K260266 | Tympendi™ (810) | Grace Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 K232646 Biodesign Otologic Butterfly Graft…score 6.0 · 3 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 |
|---|---|---|---|
| * | K033796 | Kurz Silicone Strips, Models SF-1, SF-1W, SF-1 BSSummary page 5…r 874.3620 Product Code(s) KHJ | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K033796 KURZ Silicone Strips KHJ Device Description Summary 21 CFR 807.92(a)(4) The Tympendi™ is a sterile, single-use silicone covering… | 2004 |
| † | K970910 | Xomed Silicone Block/Strip | 1997 |
| † | K981575 | Tympanostomy Tube | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 3 companies; a new generation was cleared every 22.5 years on median.
- None of the 3 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. 2026, 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?
Tympendi™ is designed to temporarily cover the tympanic membrane after surgical procedures in the middle ear and is not intended for use beyond twenty-one (21) days.
Tympendi™ serves as a physical barrier to protect the TM and underlying structures. It reduces the risk of adhesion between the TM and packing materials.
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/K260266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260266: Tympendi™ (810).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260266
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026