Cleared Traditional

K874754 - SARA DIGICAP

K874754 is the FDA 510(k) clearance for SARA DIGICAP by Ppg/Applied Resources, Inc.. It is a Class 2 Anesthesiology device (product code CCK) cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K874754 · Ppg/Applied Resources, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1988
Decision
124d
Days
Class 2
Risk

K874754 is an FDA 510(k) clearance for the SARA DIGICAP. 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 March 21, 1988 after a review of 124 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/Applied Resources, Inc. devices

Submission Details

510(k) Number K874754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1987
Decision Date March 21, 1988
Days to Decision 124 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 140d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 82
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K874754.
HEWLETT-PACKARD MODEL M1016A CO2 & M1017A FI02
K896030 · Hewlett-Packard Co. · Dec 1989
ENGSTROM ELIZA + CO2 ANALYZER
K890112 · Gambro, Inc. · Mar 1989
VITALERT 1000 MONITORING SYSTEM
K873380 · Draeger Medical, Inc. · Apr 1988
SERIES 7050 CAPNOGRAPH
K860556 · Marquette Electronics, Inc. · Feb 1986
CAPNOMED
K851658 · Draeger Medical, Inc. · May 1985
SERIES 7000 END TIDAL CO2 MONITORING SYSTEM
K851001 · Marquette Electronics, Inc. · May 1985