Cleared Traditional

K781931 - TAPE

K781931 is an FDA 510(k) clearance for TAPE, manufactured by Beiersdorf, Inc.. The device is a Class 1 General Hospital device with product code FQM cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K781931 · Beiersdorf, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1978
Decision
17d
Days
Class 1
Risk

K781931 is an FDA 510(k) clearance for the TAPE, ELASTOPLAST ELASTIC TEAR. Classified as Bandage, Elastic (product code FQM), Class I - General Controls.

Submitted by Beiersdorf, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 7, 1978 after a review of 17 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5075 - the FDA general hospital 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 Beiersdorf, Inc. devices

FDA 510(k) Submission Details - K781931

510(k) Number K781931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1978
Decision Date December 07, 1978
Days to Decision 17 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 129d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

FQM Device Classification - Class 1, General Controls

Product Code FQM Bandage, Elastic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5075
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 - FQM Bandage, Elastic

All 14
Devices cleared under the same product code (FQM) and FDA review panel - the closest regulatory comparables to K781931.
ANAGO DISP., ALL PURPOSE PATIENT REST.
K800197 · Anago, Inc. · Feb 1980
BINDAFIX
K791211 · Conphar, Inc. · Aug 1979
SECUTEX SURGICAL BINDER
K791256 · Conphar, Inc. · Aug 1979
BANDAGE
K780606 · Abco Dealers, Inc. · Apr 1978
BANDAGE, ELASTIC
K780231 · Biomet, Inc. · Feb 1978
ELASTOMULL GAUZE BANDAGE
K771758 · Beiersdorf, Inc. · Oct 1977