Cleared Traditional

K152553 - CueSee Hypoxic

K152553 is an FDA 510(k) clearance for CueSee Hypoxic, manufactured by Eurotrol B.V.. The device is a Class 1 Chemistry device with product code JJS cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K152553 · Eurotrol B.V. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
227d
Days
Class 1
Risk

K152553 is an FDA 510(k) clearance for the CueSee Hypoxic. Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by Eurotrol B.V. (Ede, NL). The FDA issued a Cleared decision on April 22, 2016 after a review of 227 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Eurotrol B.V. devices

FDA 510(k) Submission Details - K152553

510(k) Number K152553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2015
Decision Date April 22, 2016
Days to Decision 227 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
139d slower than avg
Panel avg: 88d · This submission: 227d
Pathway characteristics
Predicate-based equivalence.

JJS Device Classification - Class 1, General Controls

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 58
Devices cleared under the same product code (JJS) and FDA review panel - the closest regulatory comparables to K152553.
Hematocrit and Metabolite QUALICHECK
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HIGH METABOLITE QUALICHECK
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RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3
K130236 · Radiometer Medical Aps · Mar 2013
MISSION CONTROLS
K033063 · Diamond Diagnostics, Inc. · Dec 2003
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509
K022525 · Bio-Rad · Aug 2002
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669
K022529 · Bio-Rad · Aug 2002