Cleared Traditional

K781146 - HEMAC LASER HEMATOLOGY SYSTEM

K781146 is the FDA 510(k) clearance for HEMAC LASER HEMATOLOGY SYSTEM by Ortho Instruments. It is a Class 2 Hematology device (product code GKL) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K781146 · Ortho Instruments · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1978
Decision
66d
Days
Class 2
Risk

K781146 is an FDA 510(k) clearance for the HEMAC LASER HEMATOLOGY SYSTEM. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Ortho Instruments (Mchenry, US). The FDA issued a Cleared decision on September 14, 1978 after a review of 66 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 Ortho Instruments devices

Submission Details

510(k) Number K781146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1978
Decision Date September 14, 1978
Days to Decision 66 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 113d · This submission: 66d
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 73
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K781146.
COULTER COUNTER MODEL S PLUS
K792537 · Coulter Electronics, Inc. · Jan 1980
COULTER COUNTER-BLOOD CELL COUNTER
K792668 · Coulter Electronics, Inc. · Jan 1980
HEMO-W SYSTEM
K781628 · Coulter Electronics, Inc. · Oct 1978
SYSMEX AUTO. BLOOD CELL COUNTER, CC-120
K780909 · Toa Medical Electronics USA, Inc. · Jun 1978
SYSTEM AUTO. BLOOD CELL COUNTER CC-110
K780910 · Toa Medical Electronics USA, Inc. · Jun 1978
SYSMEX PLATELET COUNTER, PL-110
K780911 · Toa Medical Electronics USA, Inc. · Jun 1978