# K260266: Tympendi™ (810)

- Pathway: 510(k) (Traditional)
- Applicant: Grace Medical, Inc.
- Decided: Aug 18, 2026 after 202 days
- Product code: KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material))
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K974653 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033796: Kurz Silicone Strips, Models SF-1, SF-1W, SF-1 BS, Heinz Kurz GmbH Medizintechnik (2004) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K260266
Methodology: https://510kreport.com/methodology