Cleared Traditional

K901380 - CASCADE 480(TM) AUTOMATED COAGULATION A...

K901380 is the FDA 510(k) clearance for CASCADE 480(TM) AUTOMATED COAGULATION A... by Helena Laboratories. It is a Class 2 Hematology device (product code GKP) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K901380 · Helena Laboratories · Hematology device
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May 1990
Decision
64d
Days
Class 2
Risk

K901380 is an FDA 510(k) clearance for the CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430. 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 May 25, 1990 after a review of 64 days - a notably fast clearance cycle.

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: 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 Helena Laboratories devices

Submission Details

510(k) Number K901380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1990
Decision Date May 25, 1990
Days to Decision 64 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 113d · This submission: 64d
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 K901380.
CASCADE 480
K921363 · Helena Laboratories · Jun 1992
CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION
K914946 · Helena Laboratories · Jan 1992
ST-4 COAGULATION INSTRUMENT
K904297 · American Bioproducts Co. · Nov 1990
KOAGULAB 60-S COAGULATION SYSTEM
K901120 · Ortho Diagnostic Systems, Inc. · May 1990
KOAGULAB* 32-S COAGULATION SYSTEM
K885035 · Ortho Diagnostic Systems, Inc. · Feb 1989
COAG-A-MATE(R) XM
K881281 · Organon Teknika Corp. · May 1988