Cleared Traditional

K881093 - ICU SARACAP

K881093 is an FDA 510(k) clearance for ICU 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 101-day FDA review.

K881093 · Ppg/Applied Resources, Inc. · Anesthesiology device
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Jun 1988
Decision
101d
Days
Class 2
Risk

K881093 is an FDA 510(k) clearance for the ICU 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 June 24, 1988 after a review of 101 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.

FDA 510(k) Submission Details - K881093

510(k) Number K881093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1988
Decision Date June 24, 1988
Days to Decision 101 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 140d · This submission: 101d
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 K881093.
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KONTRON CAPNOGRAPH MONITOR, SUPERMON MODULE 7281
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VITALERT 1000 MONITORING SYSTEM
K873380 · Draeger Medical, Inc. · Apr 1988
BIOCHEM 9090 CAPNOGRAPH/SAO2
K873856 · Biochem International, Inc. · Dec 1987
K881093 · ICU SARACAP
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