Cleared Traditional

K993797 - EC-7701 FLUID WARMING CABINET

K993797 · Enthermics Medical Systems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K993797

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 115d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

LDQ Device Classification - Class ,

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 58
Devices cleared under the same product code (LDQ) and FDA review panel - the closest regulatory comparables to K993797.
HOT SHOT FLUID WARMER IV FLUIDS
K992258 · Infra-Med Technologies, Inc. · Jan 2000
PIV SYSTEM
K981032 · Medical Solutions, Inc. · Sep 1998
CONTROLLED TEMPERATURE CABINET SYSTEM
K973747 · Smith · May 1998
ACU-HALT
K955661 · Glederer & Co., Inc. · Dec 1996
ACU-LAB
K955776 · Glederer & Co., Inc. · Jun 1996
ACU-HALT
K945374 · Eva-Health USA, Inc. · Aug 1995
K993797 · EC-7701 FLUID WARMING CABINET
Download PDF FDA Summary Enthermics Medical Sy…