Cleared Traditional

HEAD PROTECTOR (K812473) - FDA 510(k) Clearance

Class I General Hospital device.

K812473 · Maddak, Inc. · General Hospital
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Dec 1981
Decision
93d
Days
Class 1
Risk

K812473 is an FDA 510(k) clearance for the HEAD PROTECTOR. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 2, 1981 after a review of 93 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6760 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Maddak, Inc. devices

Submission Details

510(k) Number K812473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1981
Decision Date December 02, 1981
Days to Decision 93 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 129d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FMQ Restraint, Protective
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6760
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 - FMQ Restraint, Protective

All 133
Devices cleared under the same product code (FMQ) and FDA review panel - the closest regulatory comparables to K812473.
DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT
K971742 · Depuy, Inc. · Jul 1997
POLYESTER PIL WRIST/ANKLE RESTRAINT/WRIST RESTRAINT UNIVERSAL/SOFT FLANNEL WRIST/ANKLE RESTRAINT/FOAM LIMB HOLDER
K963431 · Zimmer, Inc. · Nov 1996
MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT
K963393 · Depuy, Inc. · Oct 1996
MEDLINE ECONOMY LIMB HOLDER,DELUXE LIMB HOLDER,CINCH-TYPE LIMB HOLDER,PADDED LIMB HOLDER,ADJUSTABLE LIMB HOLDER
K963378 · Medline Industries, Inc. · Oct 1996
MEDLINE BODY HOLDER
K963360 · Medline Industries, Inc. · Oct 1996
MEDLINE SAETY VEST,MEDLINE ECONOMY VEST, MEDLINE TIE-BACK VEST, MEDLINE SECURTIY VEST, VEST RESTRAINT
K963362 · Medline Industries, Inc. · Oct 1996