Cleared Traditional

K914431 - ABSORBENT FIBER

K914431 is an FDA 510(k) clearance for ABSORBENT FIBER, manufactured by Ulti-Med Intl., Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAB cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K914431 · Ulti-Med Intl., Inc. · General & Plastic Surgery device
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Dec 1991
Decision
61d
Days
Class 1
Risk

K914431 is an FDA 510(k) clearance for the ABSORBENT FIBER. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by Ulti-Med Intl., Inc. (Glendale Hts., US). The FDA issued a Cleared decision on December 4, 1991 after a review of 61 days - a notably fast clearance 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: 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 - K914431

510(k) Number K914431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1991
Decision Date December 04, 1991
Days to Decision 61 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 115d · This submission: 61d
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 81
Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K914431.
MEPITEL NON-ADHERENT SILICONE DRESSING
K914604 · Molnlycke Clinical Products AB · Mar 1992
BANDAGE ROLL, GAUZE
K913779 · Keilei Intl., Inc. · Dec 1991
MULTIPLE BURN DRESSING
K914071 · Kerma Medical Products, Inc. · Dec 1991
GAUZE BANDAGE ROLL
K914842 · Cal West Trading Co. · Dec 1991
STERILE BANDAGE, GAUZE, FINE MESH, 3X8 INCHES
K914937 · Kerma Medical Products, Inc. · Dec 1991
CONFORMING BANDAGE
K912692 · Ulti-Med Intl., Inc. · Oct 1991
K914431 · ABSORBENT FIBER
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