Cleared Traditional

K993797 - EC-7701 FLUID WARMING CABINET (FDA 510(k) Clearance)

K993797 · Enthermics Medical Systems, Inc. · General & Plastic Surgery device
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Jan 2000
Decision
72d
Days
-
Risk

K993797 is an FDA 510(k) clearance for the EC-7701 FLUID WARMING CABINET.

Submitted by Enthermics Medical Systems, Inc. (Washington, US). The FDA issued a Cleared decision on January 20, 2000 after a review of 72 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.

View all Enthermics Medical Systems, Inc. devices

Submission Details

510(k) Number K993797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1999
Decision Date January 20, 2000
Days to Decision 72 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 114d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -