Cleared Traditional

K821483 - IL 1302 PH BLOOD GAS ANALYZER

K821483 is the FDA 510(k) clearance for IL 1302 PH BLOOD GAS ANALYZER by Instrumentation Laboratory CO. It is a Class 2 Chemistry device (product code CHL) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K821483 · Instrumentation Laboratory CO · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1982
Decision
23d
Days
Class 2
Risk

K821483 is an FDA 510(k) clearance for the IL 1302 PH BLOOD GAS ANALYZER. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on June 10, 1982 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1120 - 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K821483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1982
Decision Date June 10, 1982
Days to Decision 23 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
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1120
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 - CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

All 86
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K821483.
DIAGNOSTICS PO2 ELECTRODE CLEANER
K831010 · Fisher Scientific Co., LLC · May 1983
BATH CLEAR
K831016 · Fisher Scientific Co., LLC · May 1983
CORNING 170 PH/BLOOD GAS ANALYZER
K823570 · Corning Medical & Scientific · Dec 1982
IL MODEL 1301, PH BLOOD GAS SYSTEM
K820744 · Instrumentation Laboratory CO · Apr 1982
158 BLOOD GAS ANALYZER
K820597 · Corning Medical & Scientific · Mar 1982
CLEANING SOLUTION FOR RADIOMETER OSM2
K812623 · Fisher Scientific Co., LLC · Nov 1981