Cleared Traditional

K955340 - EUROTROL GAS - ISE CONTROL

K955340 is the FDA 510(k) clearance for EUROTROL GAS - ISE CONTROL by Direct Solutions. It is a Class 1 Chemistry device (product code JJS) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K955340 · Direct Solutions · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
36d
Days
Class 1
Risk

K955340 is an FDA 510(k) clearance for the EUROTROL GAS - ISE CONTROL. Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by Direct Solutions (Westford, US). The FDA issued a Cleared decision on December 26, 1995 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Direct Solutions devices

Submission Details

510(k) Number K955340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1995
Decision Date December 26, 1995
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 88d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJS Controls For Blood-gases, (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJS Controls For Blood-gases, (assayed And Unassayed)

All 44
Devices cleared under the same product code (JJS) and FDA review panel - the closest regulatory comparables to K955340.
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STAT PROFILE ULTRA BLOOD GAS CONTROLS
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CERTAIN(R) ELITE LEVEL 1, 2 AND 3
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