Cleared Traditional

K812216 - CUDDLE CAP

K812216 · Darcy, Inc. · General & Plastic Surgery device
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Aug 1981
Decision
15d
Days
-
Risk

K812216 is an FDA 510(k) clearance for the CUDDLE CAP.

Submitted by Darcy, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1981 after a review of 15 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 Darcy, Inc. devices

FDA 510(k) Submission Details - K812216

510(k) Number K812216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1981
Decision Date August 20, 1981
Days to Decision 15 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
100d faster than avg
Panel avg: 115d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

LDQ Device Classification - Class ,

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 40
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