Cleared Traditional

K852516 - CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE

K852516 is an FDA 510(k) clearance for CENTIFUGE, manufactured by Whittaker General Medical. The device is a Class 2 Hematology device with product code JPI cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K852516 · Whittaker General Medical · Hematology device
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Jul 1985
Decision
32d
Days
Class 2
Risk

K852516 is an FDA 510(k) clearance for the CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE. Classified as Device, Hematocrit Measuring (product code JPI), Class II - Special Controls.

Submitted by Whittaker General Medical (Richmond, US). The FDA issued a Cleared decision on July 15, 1985 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6400 - 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.

FDA 510(k) Submission Details - K852516

510(k) Number K852516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1985
Decision Date July 15, 1985
Days to Decision 32 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
81d faster than avg
Panel avg: 113d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPI Device Classification - Class 2, Special Controls

Product Code JPI Device, Hematocrit Measuring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6400
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 - JPI Device, Hematocrit Measuring

All 14
Devices cleared under the same product code (JPI) and FDA review panel - the closest regulatory comparables to K852516.
STATSPIN ILLUMINATED MICRO-HEMATOCRIT TUBE READER
K902028 · Norfolk Scientific, Inc. · Jun 1990
CHART-TYPE MICRO HEMATOCRIT TUBE READER
K870511 · Norfolk Scientific, Inc. · Mar 1987
MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94
K852482 · Em Diagnostic Systems, Inc. · Jul 1985
PLASMA EXTRACTION SYSTEM
K850391 · Hans J. Brouwers & Assoc. · May 1985
HAEMOFUGE A. BIOFUGE A. & B
K840767 · Heraeus-Christ GmbH · Apr 1984
COMPUR* M1100 HEMATRCRIT SYSTEM
K831318 · Worthington Diagnostic Systems · Jun 1983
K852516 · CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE
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