Cleared Traditional

K945374 - ACU-HALT

K945374 · Eva-Health USA, Inc. · General & Plastic Surgery device
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Aug 1995
Decision
280d
Days
-
Risk

K945374 is an FDA 510(k) clearance for the ACU-HALT.

Submitted by Eva-Health USA, Inc. (Staten Island, US). The FDA issued a Cleared decision on August 9, 1995 after a review of 280 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K945374

510(k) Number K945374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1994
Decision Date August 09, 1995
Days to Decision 280 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 115d · This submission: 280d
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 K945374.
CONTROLLED TEMPERATURE CABINET SYSTEM
K973747 · Smith · May 1998
ACU-HALT
K955661 · Glederer & Co., Inc. · Dec 1996
ACU-LAB
K955776 · Glederer & Co., Inc. · Jun 1996
PERSONAL ALARM SYSTEM (PAS)
K944961 · Cytoprobe Corp. · Aug 1995
PALCO LABS COLD POUCH
K942810 · Palco Laboratories, Inc. · Jun 1995
MEDICAL PROCEDURE TRAY, MODIFICATION
K930884 · Enpak Medical Corp. · Mar 1995
K945374 · ACU-HALT
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