Cleared Traditional

K893622 - PREEMICARE MODEL 200-II INFANT TRANSPOR...

K893622 is the FDA 510(k) clearance for PREEMICARE MODEL 200-II INFANT TRANSPOR... by Preemicare Corp.. It is a Class 2 Anesthesiology device (product code CBK) cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K893622 · Preemicare Corp. · Anesthesiology device
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Jan 1990
Decision
237d
Days
Class 2
Risk

K893622 is an FDA 510(k) clearance for the PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Preemicare Corp. (Houston, US). The FDA issued a Cleared decision on January 3, 1990 after a review of 237 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 K893622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1989
Decision Date January 03, 1990
Days to Decision 237 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 140d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 122
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K893622.
7200AE MICROPROCESSOR VENTILATOR W/ENHANCED HARD.
K902506 · Puritan Bennett Corp. · Jan 1991
OHMEDA 7800 ANESTHESIA VENTILATOR SOFTWARE UPDATE
K902084 · Ohmeda Medical · Oct 1990
PURITAN-BENNETT COMPANION 2801 VOLUME VENTILATOR
K897113 · Puritan Bennett Corp. · Mar 1990
MODIFIED PERMCATH TRAY (2ND SUBMISSION)
K895779 · Quinton, Inc. · Dec 1989
PURITAN-BENNETT 7200SPI MICROPROCESSOR VENTILATOR
K893043 · Puritan Bennett Corp. · Aug 1989
ADVENT VENTILATOR
K884793 · Ohmeda Medical · Jun 1989