Cleared Traditional

K060561 - CLEARADEX GEL

K060561 is an FDA 510(k) clearance for CLEARADEX GEL, manufactured by Cambridgemed. The device is a Class 2 Ear, Nose, Throat device with product code KHJ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K060561 · Cambridgemed · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
88d
Days
Class 2
Risk

K060561 is an FDA 510(k) clearance for the CLEARADEX GEL. Classified as Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (product code KHJ), Class II - Special Controls.

Submitted by Cambridgemed (Woburn, US). The FDA issued a Cleared decision on May 30, 2006 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cambridgemed devices

FDA 510(k) Submission Details - K060561

510(k) Number K060561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2006
Decision Date May 30, 2006
Days to Decision 88 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 89d · This submission: 88d
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 10
Devices cleared under the same product code (KHJ) and FDA review panel - the closest regulatory comparables to K060561.
Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6)
K232646 · Cook Biotech Incorporated · May 2024
GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP
K080022 · Vascular Solutions, Inc. · Dec 2008
MEROGEL OTOLOGIC PACK
K001148 · Xomed, Inc. · Jun 2000
EPIFILM OTOLOGIC LAMINA
K982870 · Xomed, Inc. · Nov 1998
XOMED SILICONE PRE-FORM BLOCKS
K982294 · Xomed, Inc. · Sep 1998
EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)
K972700 · Exmoor Plastics , Ltd. · Jul 1998