Cleared Traditional

K822306 - BIO-BAND BANDAGES

K822306 · Robert Hirschfield · General & Plastic Surgery device
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Mar 1984
Decision
594d
Days
-
Risk

K822306 is an FDA 510(k) clearance for the BIO-BAND BANDAGES. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Robert Hirschfield. The FDA issued a Cleared decision on March 15, 1984 after a review of 594 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Robert Hirschfield devices

FDA 510(k) Submission Details - K822306

510(k) Number K822306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1982
Decision Date March 15, 1984
Days to Decision 594 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
479d slower than avg
Panel avg: 115d · This submission: 594d
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 604
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K822306.
DUODERM FLEXIBLE HYDROACTIVE DRESSINGS
K841287 · Convatec, A Division of E.R. Squibb & Sons · Aug 1984
HYDRON WOUND DRESSING FAST SEAT KIT
K832699 · National Patent Development Corp. · Apr 1984
STERILE ABSORBENT GAUZE BURN & SOUND
K840745 · Chesebrough-Pond'S U.S.A. Co. · Apr 1984
NON ADHERENT BANDAGE/SHEET
K833730 · American Medical Disposable, Inc. · Jan 1984
DECUBITUS CARE ABSORBENT DRESSING
K832407 · American Pharmaseal Div. Ahsc · Jan 1984
BARD ABSORPTION DRESSING
K831710 · C.R. Bard, Inc. · Jan 1984