Cleared Traditional

EMIT TIMER UNIT #100 (K821531) - FDA 510(k) Clearance

Class I Chemistry device.

K821531 · Syva Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1982
Decision
21d
Days
Class 1
Risk

K821531 is an FDA 510(k) clearance for the EMIT TIMER UNIT #100. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on June 11, 1982 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2100 - 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

Submission Details

510(k) Number K821531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1982
Decision Date June 11, 1982
Days to Decision 21 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
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQP Calculator/data Processing Module, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2100
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 - JQP Calculator/data Processing Module, For Clinical Use

All 77
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K821531.
CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM
K892060 · Syva Co. · Aug 1989
SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER
K850659 · Syva Co. · Apr 1985
EMIT CLINICAL PROCESSOR #CP-5000
K822932 · Syva Co. · Nov 1982
SYVA LAB PROCESSOR 6000
K822381 · Syva Co. · Aug 1982
EMIT CLINICAL PROCESSOR-CP 5000
K792129 · Syva Co. · Nov 1979
THE ABBOTT EXECUTIVE
K790543 · Abbott Laboratories · May 1979