Cleared Traditional

SALT CREEK P.I. TRAY (K864682) - FDA 510(k) Clearance

K864682 · Salt Creek Medical Technologies · Cardiovascular device
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Jan 1987
Decision
35d
Days
-
Risk

K864682 is an FDA 510(k) clearance for the SALT CREEK P.I. TRAY.

Submitted by Salt Creek Medical Technologies (Canfield, US). The FDA issued a Cleared decision on January 6, 1987 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Cardiovascular 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 Salt Creek Medical Technologies devices

Submission Details

510(k) Number K864682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1986
Decision Date January 06, 1987
Days to Decision 35 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 125d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -