Cleared Traditional

K812482 - FOAM WEDGE

K812482 · Maddak, Inc. · General & Plastic Surgery device
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Sep 1981
Decision
24d
Days
-
Risk

K812482 is an FDA 510(k) clearance for the FOAM WEDGE.

Submitted by Maddak, Inc. (Walker, US). The FDA issued a Cleared decision on September 24, 1981 after a review of 24 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 Maddak, Inc. devices

Submission Details

510(k) Number K812482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1981
Decision Date September 24, 1981
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 16
Devices cleared under the same product code (LDQ) and FDA review panel - the closest regulatory comparables to K812482.
TOURNIQUET CUFF PRESSURE MONITOR #TCPM
K832272 · Electromedics, Inc. · Nov 1983
PLASTIC DISPOSABLE RAZOR
K831799 · I M, Inc. · Jul 1983
POSTURE MIRROR
K812479 · Maddak, Inc. · Dec 1981
NU-BORN BABY BATH KIT
K802366 · American Hospital Supply Corp. · Oct 1980
TUBE HOLDER
K801421 · Devon Industries, Inc. · Jul 1980
CONPHAR SURGICAL RAZORR
K791798 · Conphar, Inc. · Feb 1980