Cleared Traditional

K921465 - CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V) (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 48
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K921465.
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K160276 · Instrumentation Laboratory CO · Mar 2016
ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS
K150877 · Instrumentation Laboratory CO · Dec 2015