Cleared Traditional

K891674 - NEONATAL ENVIRONMENTAL MONITOR

K891674 is the FDA 510(k) clearance for NEONATAL ENVIRONMENTAL MONITOR by Preemicare Corp.. It is a Class 2 Anesthesiology device (product code CCL) cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K891674 · Preemicare Corp. · Anesthesiology device
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Aug 1989
Decision
163d
Days
Class 2
Risk

K891674 is an FDA 510(k) clearance for the NEONATAL ENVIRONMENTAL MONITOR, MODEL 275. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Preemicare Corp. (Houston, US). The FDA issued a Cleared decision on August 31, 1989 after a review of 163 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1720 - 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 Preemicare Corp. devices

Submission Details

510(k) Number K891674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1989
Decision Date August 31, 1989
Days to Decision 163 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 140d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CCL Analyzer, Gas, Oxygen, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1720
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 - CCL Analyzer, Gas, Oxygen, Gaseous-phase

All 20
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K891674.
HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02
K982619 · Hewlett-Packard Co. · Aug 1998
COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR
K920338 · Puritan Bennett Corp. · Aug 1992
AG-820PA FI02 MODULE
K896359 · Nihon Kohden America, Inc. · Mar 1990
MULTINEX MONITOR (MODIFICATION)
K883254 · Datascope Corp. · Sep 1988
OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR)
K882743 · Ohmeda Medical · Aug 1988
OHMEDA 5120 OXYGEN MONITOR
K853082 · Ohmeda Medical · Jul 1985