Cleared Traditional

K972446 - PEDO CUSH PEDO CUDDLE

K972446 is an FDA 510(k) clearance for PEDO CUSH PEDO CUDDLE, manufactured by Cavity Free Kids, Inc.. The device is a Class 1 General Hospital device with product code FMQ cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K972446 · Cavity Free Kids, Inc. · General Hospital
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Nov 1997
Decision
136d
Days
Class 1
Risk

K972446 is an FDA 510(k) clearance for the PEDO CUSH PEDO CUDDLE. Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Cavity Free Kids, Inc. (St. Paul, US). The FDA issued a Cleared decision on November 13, 1997 after a review of 136 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 Cavity Free Kids, Inc. devices

FDA 510(k) Submission Details - K972446

510(k) Number K972446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1997
Decision Date November 13, 1997
Days to Decision 136 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 129d · This submission: 136d
Pathway characteristics
Predicate-based equivalence.

FMQ Device Classification - Class 1, General Controls

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 66
Devices cleared under the same product code (FMQ) and FDA review panel - the closest regulatory comparables to K972446.
CENTURION PROTECTIVE RESTRAINT, SCR SERIES
K080448 · Tri-State Hospital Supply Corp. · Aug 2008
INFANT LIMB HOLDER, MODELS 306080 & 306081
K010818 · Skil-Care Corp. · May 2001
CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025
K010644 · Skil-Care Corp. · May 2001
FULL BODY RESTRAINT SYSTEM
K972046 · Gillen Industries · Aug 1997
PATIENT RESTRAINT
K971948 · E.M. Adams Co., Inc. · Aug 1997
PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905
K972123 · Smith · Jul 1997