Cleared Traditional

K821575 - SYSMEX CC-800

K821575 is an FDA 510(k) clearance for SYSMEX CC-800, manufactured by Sysmex/Toa Medical Electronics, Inc.. The device is a Class 2 Hematology device with product code GKL cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K821575 · Sysmex/Toa Medical Electronics, Inc. · Hematology device
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Jul 1982
Decision
36d
Days
Class 2
Risk

K821575 is an FDA 510(k) clearance for the SYSMEX CC-800. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Sysmex/Toa Medical Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 2, 1982 after a review of 36 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.

FDA 510(k) Submission Details - K821575

510(k) Number K821575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1982
Decision Date July 02, 1982
Days to Decision 36 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
77d faster than avg
Panel avg: 113d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKL Device Classification - Class 2, Special Controls

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 124
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K821575.
PROFILE 750 BLOOD CELL COUNTER
K823886 · Mallinckrodt Critical Care · Mar 1983
HEMATOLOGY ANALYZER
K823344 · Abbott Diagnostics · Dec 1982
SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY
K822758 · Toa Medical Electronics USA, Inc. · Oct 1982
CC-700 SEVEN PARAMETER, AUTOMATED HEMAA
K821238 · Dysmex · May 1982
TECHNICON H6000 (90/HR) HEMATOLOGY SYS
K811978 · Technicon Instruments Corp. · Aug 1981
LPC II
K812031 · Labtronix Corp. · Aug 1981
K821575 · SYSMEX CC-800
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