Cleared Traditional

K260266 - Tympendi™ (810)

K260266 is an FDA 510(k) clearance for Tympendi (810), manufactured by Grace Medical, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code KHJ cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K260266 · Grace Medical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
202d
Days
Class 2
Risk

K260266 is an FDA 510(k) clearance for the Tympendi™ (810). Classified as Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (product code KHJ), Class II - Special Controls.

Submitted by Grace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on August 18, 2026 after a review of 202 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3620 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Grace Medical, Inc. devices

FDA 510(k) Submission Details - K260266

510(k) Number K260266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2026
Decision Date August 18, 2026
Days to Decision 202 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 90d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHJ Device Classification - Class 2, Special Controls

Product Code KHJ Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - KHJ Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)

All 27
Devices cleared under the same product code (KHJ) and FDA review panel - the closest regulatory comparables to K260266.
Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6)
K232646 · Cook Biotech Incorporated · May 2024
Biodesign Otologic Repair Graft
K161000 · Cook Biotech Incorporated · May 2016
Biodesign Otologic Repair Graft
K150594 · Cook Biotech Incorprated · Sep 2015
ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI
K132198 · Ceremed , Inc. · Sep 2013
BIODESIGN ENT REPAIR GRAFT
K121360 · Cook Biotech Incorprated · Feb 2013
ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN
K122561 · Ceremed , Inc. · Nov 2012