Cleared Traditional

K820224 - EMIT FREELEVEL SYSTEM I

K820224 is an FDA 510(k) clearance for EMIT FREELEVEL SYSTEM I, manufactured by Syva Co.. The device is a Class 1 Chemistry device with product code JRL cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K820224 · Syva Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1982
Decision
27d
Days
Class 1
Risk

K820224 is an FDA 510(k) clearance for the EMIT FREELEVEL SYSTEM I. Classified as Unit, Filter, Membrane (product code JRL), Class I - General Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on February 23, 1982 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2050 - the FDA in vitro diagnostics and chemistry 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 Syva Co. devices

FDA 510(k) Submission Details - K820224

510(k) Number K820224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1982
Decision Date February 23, 1982
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

JRL Device Classification - Class 1, General Controls

Product Code JRL Unit, Filter, Membrane
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2050
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 - JRL Unit, Filter, Membrane

All 8
Devices cleared under the same product code (JRL) and FDA review panel - the closest regulatory comparables to K820224.
ACRO PACK
K822121 · Gelman Sciences, Inc. · Aug 1982
CENTRIFREE MICROPARTITION SYSTEM
K820455 · Amicon, Inc. · Mar 1982
IL 703, STAT SEPARATOR
K812750 · Instrumentation Laboratory CO · Jan 1982
VACUSHIELD TM
K813159 · Gelman Sciences, Inc. · Dec 1981
ACRODISC
K810829 · Gelman Sciences, Inc. · Apr 1981
ULTRAFREE CALCIUM FILTER
K801500 · Millipore Corp. · Aug 1980