Cleared Traditional

K790030 - FLUID

K790030 is the FDA 510(k) clearance for FLUID by Sysmex Corp.. It is a Class 2 Hematology device (product code GKR) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K790030 · Sysmex Corp. · Hematology device
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Feb 1979
Decision
36d
Days
Class 2
Risk

K790030 is an FDA 510(k) clearance for the FLUID, RHEMOX-HB LYSING. Classified as System, Hemoglobin, Automated (product code GKR), Class II - Special Controls.

Submitted by Sysmex Corp. (Mchenry, US). The FDA issued a Cleared decision on February 8, 1979 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5620 - 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 Sysmex Corp. devices

Submission Details

510(k) Number K790030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1979
Decision Date February 08, 1979
Days to Decision 36 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
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.

Device Classification

Product Code GKR System, Hemoglobin, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5620
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 - GKR System, Hemoglobin, Automated

All 19
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K790030.
HEMESPEC II
K803015 · Helena Laboratories · Dec 1980
HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.
K803016 · Helena Laboratories · Dec 1980
HGB3 (1:251)
K802266 · R&D Systems, Inc. · Oct 1980
SYSING AND HEMOGLOBIN REAGENT
K780829 · Harleco · Jun 1978
BLANKING SOLUTION HGB
K771789 · J.T. Baker Chemical Co. · Oct 1977