Cleared Traditional

K915821 - MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES

K915821 is an FDA 510(k) clearance for MULTIPLE STERILE GAUZE BANDAGE ROLLS, manufactured by Kerma Medical Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAB cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K915821 · Kerma Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
151d
Days
Class 1
Risk

K915821 is an FDA 510(k) clearance for the MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by Kerma Medical Products, Inc. (Chesapeake, US). The FDA issued a Cleared decision on May 29, 1992 after a review of 151 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4014 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Kerma Medical Products, Inc. devices

FDA 510(k) Submission Details - K915821

510(k) Number K915821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1991
Decision Date May 29, 1992
Days to Decision 151 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
36d slower than avg
Panel avg: 115d · This submission: 151d
Pathway characteristics
Predicate-based equivalence.

NAB Device Classification - Class 1, General Controls

Product Code NAB Gauze / Sponge,nonresorbable For External Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4014
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.

Regulatory Peers - NAB Gauze / Sponge,nonresorbable For External Use

All 34
Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K915821.
PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE
K920282 · Trinity Laboratories, Inc. · May 1992
ABSORBENT FIBER
K914431 · Ulti-Med Intl., Inc. · Dec 1991
CONFORMING BANDAGE
K912692 · Ulti-Med Intl., Inc. · Oct 1991
POST OPERATIVE SPONGE
K912693 · Ulti-Med Intl., Inc. · Oct 1991
NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING
K891101 · Smith & Nephew United, Inc. · Apr 1989
ABSORBENT GAUZE ROLL
K890672 · Smith & Nephew United, Inc. · Apr 1989