Cleared Traditional

K873742 - HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K873742 · Hood Laboratories · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1987
Decision
15d
Days
Class 2
Risk

K873742 is an FDA 510(k) clearance for the HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES. Classified as Prosthesis, Tracheal, Preformed/molded (product code NWA), Class II - Special Controls.

Submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on October 1, 1987 after a review of 15 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3720 - 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 Hood Laboratories devices

Submission Details

510(k) Number K873742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1987
Decision Date October 01, 1987
Days to Decision 15 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 114d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NWA Prosthesis, Tracheal, Preformed/molded
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3720
Definition The Device Is Intended To Provide Support To Weakened Or Constricting Airway Walls.
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.