Cleared Traditional

K931956 - CASCADE M

K931956 is the FDA 510(k) clearance for CASCADE M by Helena Laboratories. It is a Class 2 Hematology device (product code GKP) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K931956 · Helena Laboratories · Hematology device
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Aug 1993
Decision
125d
Days
Class 2
Risk

K931956 is an FDA 510(k) clearance for the CASCADE M, CAT. NO. 1710. Classified as Instrument, Coagulation, Automated (product code GKP), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on August 23, 1993 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5400 - the FDA hematology device framework. 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Helena Laboratories devices

Submission Details

510(k) Number K931956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1993
Decision Date August 23, 1993
Days to Decision 125 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 113d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKP Instrument, Coagulation, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GKP Instrument, Coagulation, Automated

All 36
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K931956.
MICROSAMPLE COAGULATION ANALYZER
K943153 · Bio/Data Corp. · Mar 1995
STA AUTOMATED MULTI-PARAMETRIC ANALYZER
K942117 · American Bioproducts Co. · Feb 1995
HEMOLAB
K931992 · Biomerieux Vitek, Inc. · Dec 1994
IL MCL-2 COAGULATION ANALYZER
K924098 · Instrumentation Laboratory CO · Jun 1993
CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)
K921465 · Helena Laboratories · Jun 1992
CASCADE 480
K921363 · Helena Laboratories · Jun 1992