Cleared Traditional

BPA, BODY POSITION ALARM (K902669) - FDA 510(k) Clearance

K902669 · Bagrad · Physical Medicine device
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Jul 1990
Decision
39d
Days
-
Risk

K902669 is an FDA 510(k) clearance for the BPA, BODY POSITION ALARM. Classified as Monitor, Spine Curvature (product code LZW).

Submitted by Bagrad (Orange Park, US). The FDA issued a Cleared decision on July 27, 1990 after a review of 39 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 Bagrad devices

Submission Details

510(k) Number K902669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1990
Decision Date July 27, 1990
Days to Decision 39 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
76d faster than avg
Panel avg: 115d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZW Monitor, Spine Curvature
Device Class -