Cleared Traditional

K894053 - 2ND MODIFICATION OF FEF(TM) END-TIDAL CO2 DETECTOR

K894053 is an FDA 510(k) clearance for 2ND MODIFICATION OF FEF(TM) END-TIDAL C..., manufactured by Fenem, Inc.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K894053 · Fenem, Inc. · Anesthesiology device
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Jul 1989
Decision
43d
Days
Class 2
Risk

K894053 is an FDA 510(k) clearance for the 2ND MODIFICATION OF FEF(TM) END-TIDAL CO2 DETECTOR. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Fenem, Inc. (New York, US). The FDA issued a Cleared decision on July 20, 1989 after a review of 43 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K894053

510(k) Number K894053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1989
Decision Date July 20, 1989
Days to Decision 43 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
97d faster than avg
Panel avg: 140d · This submission: 43d
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 273
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K894053.
CAPNOMAC II(TM) ANESTHESIA MULTIGAS MONITOR
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K893589 · Marquette Gas Analysis Corp. · Jul 1989
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K892406 · Salter Labs · Jul 1989
BIOCHEM 520 BREATH INDICATOR
K890874 · Biochem International, Inc. · Jun 1989
ENGSTROM ELIZA + CO2 ANALYZER
K890112 · Gambro, Inc. · Mar 1989
THE SYSTEM, SARA DIGICAP PLUS OHMEDA MINX OXIMETER
K884158 · Ppg Industries, Inc. · Jan 1989
K894053 · 2ND MODIFICATION OF FEF(TM) END-TIDAL CO2 DETECTOR
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