Cleared Traditional

CLINAK(TM) ISE SUBSYSTEM (K910554) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K910554 · Baxter Healthcare Corp · Chemistry device
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Mar 1991
Decision
34d
Days
Class 2
Risk

K910554 is an FDA 510(k) clearance for the CLINAK(TM) ISE SUBSYSTEM. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on March 6, 1991 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1665 - 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 K910554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1991
Decision Date March 06, 1991
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JGS Electrode, Ion Specific, Sodium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1665
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JGS Electrode, Ion Specific, Sodium

All 35
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K910554.
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL)
K924471 · Eastman Kodak Company · Nov 1992
ISE/NA+
K912648 · Boehringer Mannheim Corp. · Jul 1991
IL PHOENIX(TM), MODEL 905 CHEM/ELECT ANALYZER
K912016 · Instrumentation Laboratory CO · Jun 1991
ABBOTT VISION LYTE (TM) SODIUM
K903188 · Abbott Laboratories · Sep 1990
LYTENING(TM) 5, LYTENING(TM) SYSTEM 30
K896526 · Baxter Healthcare Corp · Jan 1990
ELECTROLYTE ANALYZER ACCESSORY FOR HITACHI 704
K861696 · Boehringer Mannheim Corp. · Jul 1986