Cleared Traditional

DYLNAMEDICS A.S.A.P. (K924973) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924973 · Dynamedics, Inc. · Physical Medicine device
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Oct 1993
Decision
380d
Days
Class 2
Risk

K924973 is an FDA 510(k) clearance for the DYLNAMEDICS A.S.A.P.. Classified as Bed, Air Fluidized (product code INX), Class II - Special Controls.

Submitted by Dynamedics, Inc. (Canada, N6b3n5, CA). The FDA issued a Cleared decision on October 15, 1993 after a review of 380 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5160 - the FDA physical medicine 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Dynamedics, Inc. devices

Submission Details

510(k) Number K924973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1992
Decision Date October 15, 1993
Days to Decision 380 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
265d slower than avg
Panel avg: 115d · This submission: 380d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code INX Bed, Air Fluidized
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.