Cleared Traditional

K823886 - PROFILE 750 BLOOD CELL COUNTER

K823886 is the FDA 510(k) clearance for PROFILE 750 BLOOD CELL COUNTER by Mallinckrodt Critical Care. It is a Class 2 Hematology device (product code GKL) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K823886 · Mallinckrodt Critical Care · Hematology device

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Mar 1983

Decision

64d

Days

Class 2

Risk

K823886 is an FDA 510(k) clearance for the PROFILE 750 BLOOD CELL COUNTER. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Mallinckrodt Critical Care (Walker, US). The FDA issued a Cleared decision on March 1, 1983 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5200 - 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 Mallinckrodt Critical Care devices

Submission Details

510(k) Number	K823886 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 27, 1982
Decision Date	March 01, 1983
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	GKL Counter, Cell, Automated (particle Counter)
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 864.5200

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 - GKL Counter, Cell, Automated (particle Counter)

All 82

Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K823886.

SYSMEX CC-150

K830506 · Toa Medical Electronics USA, Inc. · May 1983

SYSMEX CC-180

K830508 · Toa Medical Electronics USA, Inc. · May 1983

QBC CENTRIFUGAL HEMATOLOGY SYS

K830451 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1983

HEMATOLOGY ANALYZER

K823344 · Abbott Diagnostics · Dec 1982

SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY

K822758 · Toa Medical Electronics USA, Inc. · Oct 1982

TECHNICON H6000 (90/HR) HEMATOLOGY SYS

K811978 · Technicon Instruments Corp. · Aug 1981

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K823886

Mallinckrodt Critical Care

Walker, MI · US

Regulatory profile

92 submissions 92 cleared

100% clearance rate · Active in Hematology

Data Intelligence Layer

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