Cleared Traditional

K881002 - O.R. SARACAP

K881002 is an FDA 510(k) clearance for O.R. SARACAP, manufactured by Ppg/Applied Resources, Inc.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K881002 · Ppg/Applied Resources, Inc. · Anesthesiology device
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Aug 1988
Decision
159d
Days
Class 2
Risk

K881002 is an FDA 510(k) clearance for the O.R. SARACAP. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Ppg/Applied Resources, Inc. (Lenexa, US). The FDA issued a Cleared decision on August 15, 1988 after a review of 159 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K881002

510(k) Number K881002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1988
Decision Date August 15, 1988
Days to Decision 159 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 140d · This submission: 159d
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 278
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K881002.
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K873856 · Biochem International, Inc. · Dec 1987
K881002 · O.R. SARACAP
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