Cleared Traditional

K921465 - CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)

K921465 is an FDA 510(k) clearance for CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V), manufactured by Helena Laboratories. The device is a Class 2 Hematology device with product code GKP cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K921465 · Helena Laboratories · Hematology device
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Jun 1992
Decision
94d
Days
Class 2
Risk

K921465 is an FDA 510(k) clearance for the CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V). 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 June 29, 1992 after a review of 94 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

FDA 510(k) Submission Details - K921465

510(k) Number K921465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1992
Decision Date June 29, 1992
Days to Decision 94 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
19d faster than avg
Panel avg: 113d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKP Device Classification - Class 2, Special Controls

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 45
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K921465.
ELECTRA 1600C AUTOMATIC COAGULATION TIMER
K931206 · Medical Laboratory Automation Systems, Inc. · Aug 1993
CASCADE M, CAT. NO. 1710
K931956 · Helena Laboratories · Aug 1993
IL MCL-2 COAGULATION ANALYZER
K924098 · Instrumentation Laboratory CO · Jun 1993
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