Cleared Traditional

K812479 - POSTURE MIRROR

K812479 · Maddak, Inc. · General & Plastic Surgery device
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Dec 1981
Decision
100d
Days
-
Risk

K812479 is an FDA 510(k) clearance for the POSTURE MIRROR.

Submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 9, 1981 after a review of 100 days - within the typical 510(k) review window.

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: 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 Maddak, Inc. devices

Submission Details

510(k) Number K812479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1981
Decision Date December 09, 1981
Days to Decision 100 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
15d faster than avg
Panel avg: 115d · This submission: 100d
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 K812479.
STERILE RUBBER BANDS
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TOURNIQUET CUFF PRESSURE MONITOR #TCPM
K832272 · Electromedics, Inc. · Nov 1983
PLASTIC DISPOSABLE RAZOR
K831799 · I M, Inc. · Jul 1983
FOAM WEDGE
K812482 · Maddak, Inc. · Sep 1981
NU-BORN BABY BATH KIT
K802366 · American Hospital Supply Corp. · Oct 1980
TUBE HOLDER
K801421 · Devon Industries, Inc. · Jul 1980