Cleared Traditional

K853726 - LARYNGEAL

K853726 is an FDA 510(k) clearance for LARYNGEAL, manufactured by Hood Laboratories. The device is a Class 2 Ear, Nose, Throat device with product code FWN cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K853726 · Hood Laboratories · Ear, Nose, Throat device
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Mar 1986
Decision
187d
Days
Class 2
Risk

K853726 is an FDA 510(k) clearance for the LARYNGEAL. Classified as Prosthesis, Larynx (stents And Keels) (product code FWN), Class II - Special Controls.

Submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on March 12, 1986 after a review of 187 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 Hood Laboratories devices

FDA 510(k) Submission Details - K853726

510(k) Number K853726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1985
Decision Date March 12, 1986
Days to Decision 187 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 90d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FWN Device Classification - Class 2, Special Controls

Product Code FWN Prosthesis, Larynx (stents And Keels)
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 - FWN Prosthesis, Larynx (stents And Keels)

All 7
Devices cleared under the same product code (FWN) and FDA review panel - the closest regulatory comparables to K853726.
LORENZ STENT
K896667 · Walter Lorenz Surgical, Inc. · Feb 1990
SILICONE LARYNGEAL STENT
K884810 · Hood Laboratories · May 1989
'EXMOOR' DAS GUPTA LARYNGEAL KEEL
K864936 · Exmoor Plastics , Ltd. · Apr 1987
MONTG. LARYNGEAL KEEL
K842800 · Boston Medical Products, Inc. · Aug 1984
MONTGOMERY LARYNGEAL STENT
K842287 · Boston Medical Products, Inc. · Jun 1984