Cleared Traditional

CueSee Hypoxic (K152553) - FDA 510(k) Clearance

Class I Chemistry device.

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

Submission Details

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.

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.