Cleared Traditional

K901141 - PARAMAX 520

K901141 is the FDA 510(k) clearance for PARAMAX 520 by Baxter Healthcare Corp. It is a Class 1 Chemistry device (product code JJC) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K901141 · Baxter Healthcare Corp · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1990
Decision
27d
Days
Class 1
Risk

K901141 is an FDA 510(k) clearance for the PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX. Classified as Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use (product code JJC), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on April 9, 1990 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2150 - 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K901141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1990
Decision Date April 09, 1990
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.

Device Classification

Product Code JJC Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2150
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 - JJC Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use

All 20
Devices cleared under the same product code (JJC) and FDA review panel - the closest regulatory comparables to K901141.
AVL OMNI ANALYZER
K945915 · Avl Scientific Corp. · Apr 1995
NOVA 16 ANALYZER
K945584 · Nova Biomedical Corp. · Feb 1995
TECHNICON RA-2000(TM) SYSTEM
K901410 · Technicon Instruments Corp. · Jul 1990
RFA/2 RAPID FLOW ANALYZER W/COMPUTER
K890332 · Alpkem Corp. · Feb 1989
AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030
K881056 · American Research Products Co. · Nov 1988
TECHNICON SMAC 3 SYSTEM
K875105 · Technicon Instruments Corp. · Feb 1988