Cleared Traditional

IL 1312, PH BLOOD GAS MANAGER (K842042) - FDA 510(k) Clearance

K842042 · Instrumentation Laboratory CO · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1984
Decision
51d
Days
-
Risk

K842042 is an FDA 510(k) clearance for the IL 1312, PH BLOOD GAS MANAGER.

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on July 11, 1984 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel. 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 K842042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1984
Decision Date July 11, 1984
Days to Decision 51 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 88d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -