Cleared Traditional

DUET (K934970) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K934970 · Trulife , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
53d
Days
Class 1
Risk

K934970 is an FDA 510(k) clearance for the DUET. Classified as Prosthesis, Adhesive, External (product code GBJ), Class I - General Controls.

Submitted by Trulife , Ltd. (Dublin 24, IE). The FDA issued a Cleared decision on December 10, 1993 after a review of 53 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3750 - 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 Trulife , Ltd. devices

Submission Details

510(k) Number K934970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1993
Decision Date December 10, 1993
Days to Decision 53 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 115d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GBJ Prosthesis, Adhesive, External
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.3750
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.