Cleared Traditional

K912055 - SYVA EDMS

K912055 is an FDA 510(k) clearance for SYVA EDMS, manufactured by Syva Co.. The device is a Class 1 Chemistry device with product code JJF cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K912055 · Syva Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1991
Decision
32d
Days
Class 1
Risk

K912055 is an FDA 510(k) clearance for the SYVA EDMS. Classified as Analyzer, Chemistry, Micro, For Clinical Use (product code JJF), Class I - General Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on June 10, 1991 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2170 - 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 - K912055

510(k) Number K912055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1991
Decision Date June 10, 1991
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

JJF Device Classification - Class 1, General Controls

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 44
Devices cleared under the same product code (JJF) and FDA review panel - the closest regulatory comparables to K912055.
HCL - 200 BIOCHEMISTRY ANALYZER
K964409 · Hcl Laboratory Systems, Inc. · Jan 1997
BRIO AUTOMATIC SAMPLINC UNIT
K961209 · Seac S.R.L. · Dec 1996
SYSTEM 6300 SERIES HIGH PERFORMANCE AMINO ACID ANA
K925093 · Beckman Instruments, Inc. · Nov 1993
SYVA(R) ETS(R) PLUS SYSTEM
K903357 · Syva Co. · Sep 1990
MODIFIED PK300 AUTOMATIC EIA ANALYZER
K893768 · Olympus Corp. · Aug 1989
RFA-300 RAPID FLOW ANALYZER W/COMPUTER
K883020 · Alpkem Corp. · Sep 1988