Cleared Traditional

SPORTS RECORDER (SR-10) (K761075) - FDA 510(k) Clearance

K761075 · Eldeco · Physical Medicine device
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Dec 1976
Decision
39d
Days
-
Risk

K761075 is an FDA 510(k) clearance for the SPORTS RECORDER (SR-10).

Submitted by Eldeco (Mchenry, US). The FDA issued a Cleared decision on December 28, 1976 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.

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Submission Details

510(k) Number K761075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1976
Decision Date December 28, 1976
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 -
Device Class -