Cleared Traditional

K971481 - DURALASTIC ANATOMICAL NASAL IMPLANTS

K971481 is an FDA 510(k) clearance for DURALASTIC ANATOMICAL NASAL IMPLANTS, manufactured by Allied Biomedical Corp.. The device is a Class 2 General & Plastic Surgery device with product code FZE cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K971481 · Allied Biomedical Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
86d
Days
Class 2
Risk

K971481 is an FDA 510(k) clearance for the DURALASTIC ANATOMICAL NASAL IMPLANTS. Classified as Prosthesis, Nose, Internal (product code FZE), Class II - Special Controls.

Submitted by Allied Biomedical Corp. (Paso Robles, US). The FDA issued a Cleared decision on July 18, 1997 after a review of 86 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3680 - the FDA general and plastic surgery 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 Allied Biomedical Corp. devices

FDA 510(k) Submission Details - K971481

510(k) Number K971481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1997
Decision Date July 18, 1997
Days to Decision 86 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 115d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FZE Device Classification - Class 2, Special Controls

Product Code FZE Prosthesis, Nose, Internal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3680
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FZE Prosthesis, Nose, Internal

All 21
Devices cleared under the same product code (FZE) and FDA review panel - the closest regulatory comparables to K971481.
SEARE BIOMEDICAL NASAL IMPLANTS
K982753 · Seare Biomedical Corp. · Sep 1998
SILIMED NASAL L SHAPED IMPLANT
K981833 · Silimed, LLC · Jun 1998
DURALASTIC ANATOMICAL NASAL IMPLANTS
K973573 · Hanson Medical, Inc. · Nov 1997
IMPLANTECH JEJ PERI-PYRIFORM IMPLANT
K962824 · Implantech Associates, Inc. · Oct 1996
BA-CPAS
K945154 · Nobelpharma USA, Inc. · Jan 1995
IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II
K941960 · Implantech Associates, Inc. · Aug 1994