Cleared Traditional

SARNS MEDICAL CART (K892052) - FDA 510(k) Clearance

K892052 · 3M Company · General & Plastic Surgery device
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Jun 1989
Decision
78d
Days
-
Risk

K892052 is an FDA 510(k) clearance for the SARNS MEDICAL CART.

Submitted by 3M Company (Ann Arbor, US). The FDA issued a Cleared decision on June 15, 1989 after a review of 78 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery 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 K892052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1989
Decision Date June 15, 1989
Days to Decision 78 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 115d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -