Cleared Traditional

P.D. CRADLE (K811657) - FDA 510(k) Clearance

K811657 · Lung Care, Inc. · Physical Medicine device
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Jul 1981
Decision
20d
Days
-
Risk

K811657 is an FDA 510(k) clearance for the P.D. CRADLE.

Submitted by Lung Care, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 1, 1981 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Physical Medicine 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 Lung Care, Inc. devices

Submission Details

510(k) Number K811657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1981
Decision Date July 01, 1981
Days to Decision 20 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 115d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -