Cleared Traditional

K781606 - MEPA-1 BLOOD ANALYZER

K781606 is the FDA 510(k) clearance for MEPA-1 BLOOD ANALYZER by Medico Electronic, Inc.. It is a Class 1 Hematology device (product code JJF) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K781606 · Medico Electronic, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1978
Decision
15d
Days
Class 1
Risk

K781606 is an FDA 510(k) clearance for the MEPA-1 BLOOD ANALYZER. Classified as Analyzer, Chemistry, Micro, For Clinical Use (product code JJF), Class I - General Controls.

Submitted by Medico Electronic, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 3, 1978 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.2170 - 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 Medico Electronic, Inc. devices

Submission Details

510(k) Number K781606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1978
Decision Date October 03, 1978
Days to Decision 15 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 113d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJF Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2170
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJF Analyzer, Chemistry, Micro, For Clinical Use

All 35
Devices cleared under the same product code (JJF) and FDA review panel - the closest regulatory comparables to K781606.
ASTRA PRINTER PAPER #88112-CHLORIDE SILV
K802392 · Hi Chem, Inc. · Oct 1980
REAGENT KIT, LANCER GLUCOSE
K790197 · Sherwood Medical Industries · Mar 1979
BECKMAN ASTRA SYSTEM
K781442 · Beckman Instruments, Inc. · Oct 1978
STAC SYSTEM
K771821 · Technicon Instruments Corp. · Nov 1977
STAC SYSTEM-ADDI. ANALYTES
K771939 · Technicon Instruments Corp. · Nov 1977
KEM-O-MAT
K771513 · Coulter Electronics, Inc. · Aug 1977