Cleared Traditional

K853185 - CUDDLE CUSHION

K853185 · The Cuddle Co. · General & Plastic Surgery device
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Aug 1985
Decision
21d
Days
-
Risk

K853185 is an FDA 510(k) clearance for the CUDDLE CUSHION.

Submitted by The Cuddle Co. (Chattanooga, US). The FDA issued a Cleared decision on August 20, 1985 after a review of 21 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 The Cuddle Co. devices

FDA 510(k) Submission Details - K853185

510(k) Number K853185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1985
Decision Date August 20, 1985
Days to Decision 21 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

LDQ Device Classification - Class ,

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 40
Devices cleared under the same product code (LDQ) and FDA review panel - the closest regulatory comparables to K853185.
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STERILE GENERAL HOSPITAL SUPPLIES
K851390 · Biological & Environmental Control Laboratories · May 1985
DISPOS. POLY APRONS
K842016 · Abco Dealers, Inc. · Jul 1984
STERILE LABELS
K834062 · Devon Industries, Inc. · Feb 1984