Cleared Traditional

K080471 - RADIO BIOAQUACARE

K080471 · Bioartificial Gel Technologies (Bagtech), Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
13d
Days
-
Risk

K080471 is an FDA 510(k) clearance for the RADIO BIOAQUACARE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Bioartificial Gel Technologies (Bagtech), Inc. (Washington, US). The FDA issued a Cleared decision on March 5, 2008 after a review of 13 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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.

FDA 510(k) Submission Details - K080471

510(k) Number K080471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2008
Decision Date March 05, 2008
Days to Decision 13 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 668
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K080471 · RADIO BIOAQUACARE
Download PDF FDA Summary Bioartificial Gel Tec…