Cleared Traditional

K801421 - TUBE HOLDER

K801421 · Devon Industries, Inc. · General & Plastic Surgery device
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Jul 1980
Decision
41d
Days
-
Risk

K801421 is an FDA 510(k) clearance for the TUBE HOLDER.

Submitted by Devon Industries, Inc. (Walker, US). The FDA issued a Cleared decision on July 28, 1980 after a review of 41 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.

View all Devon Industries, Inc. devices

FDA 510(k) Submission Details - K801421

510(k) Number K801421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1980
Decision Date July 28, 1980
Days to Decision 41 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

LDQ Device Classification - Class ,

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 23
Devices cleared under the same product code (LDQ) and FDA review panel - the closest regulatory comparables to K801421.
AMPCO SKIN SCRUB TRAYS, CAT.#SS843
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PLASTIC DISPOSABLE RAZOR CAT.#1017,1018
K802003 · Pollak (Intl.), Ltd. · Sep 1980
AMPCO SKIN SCRUB TRAYS, CAT.#SS612
K802044 · Associated Medical Products Co. · Sep 1980
CONPHAR SURGICAL RAZORR
K791798 · Conphar, Inc. · Feb 1980
CUT-DOWN BUILT-UP TOILET SEAT
K772403 · Fred Sammons, Inc. · Feb 1978
ISOLATION KIT
K770381 · American Hospital Supply Corp. · Apr 1977