Cleared Traditional

K961335 - GEM PREMIER PLUS MODEL 5500

K961335 is an FDA 510(k) clearance for GEM PREMIER PLUS MODEL 5500, manufactured by Mallinckrodt Sensor Systems, Inc.. The device is a Class 2 Chemistry device with product code CHL cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K961335 · Mallinckrodt Sensor Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
81d
Days
Class 2
Risk

K961335 is an FDA 510(k) clearance for the GEM PREMIER PLUS MODEL 5500. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Mallinckrodt Sensor Systems, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on June 28, 1996 after a review of 81 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 Mallinckrodt Sensor Systems, Inc. devices

FDA 510(k) Submission Details - K961335

510(k) Number K961335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1996
Decision Date June 28, 1996
Days to Decision 81 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 88d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CHL Device Classification - Class 2, Special Controls

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

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