Cleared Special

K000712 - PORTABLE INTENSIVE CARE UNIT

K000712 is an FDA 510(k) clearance for PORTABLE INTENSIVE CARE UNIT, manufactured by Medical Research Laboratories, Inc.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Special 510(k) pathway after a 56-day FDA review.

K000712 · Medical Research Laboratories, Inc. · Anesthesiology device
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Apr 2000
Decision
56d
Days
Class 2
Risk

K000712 is an FDA 510(k) clearance for the PORTABLE INTENSIVE CARE UNIT, MODEL PIC. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Medical Research Laboratories, Inc. (Buffalo Grove, US). The FDA issued a Cleared decision on April 27, 2000 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medical Research Laboratories, Inc. devices

FDA 510(k) Submission Details - K000712

510(k) Number K000712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2000
Decision Date April 27, 2000
Days to Decision 56 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 140d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

CCK Device Classification - Class 2, Special Controls

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

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