Cleared Traditional

K884158 - THE SYSTEM, SARA DIGICAP PLUS OHMEDA MINX OXIMETER

K884158 is an FDA 510(k) clearance for THE SYSTEM, manufactured by Ppg Industries, Inc.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K884158 · Ppg Industries, Inc. · Anesthesiology device
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Jan 1989
Decision
105d
Days
Class 2
Risk

K884158 is an FDA 510(k) clearance for the THE SYSTEM, SARA DIGICAP PLUS OHMEDA MINX OXIMETER. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Ppg Industries, Inc. (Lenexa, US). The FDA issued a Cleared decision on January 17, 1989 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - the FDA anesthesiology and respiratory device 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ppg Industries, Inc. devices

FDA 510(k) Submission Details - K884158

510(k) Number K884158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1988
Decision Date January 17, 1989
Days to Decision 105 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 140d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 196
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