Cleared Traditional

K911450 - INFANT VENTILATOR

K911450 is the FDA 510(k) clearance for INFANT VENTILATOR by Preemicare Corp.. It is a Class 2 Anesthesiology device (product code CBK) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K911450 · Preemicare Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1991
Decision
85d
Days
Class 2
Risk

K911450 is an FDA 510(k) clearance for the INFANT VENTILATOR. 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 June 18, 1991 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Preemicare Corp. devices

Submission Details

510(k) Number K911450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1991
Decision Date June 18, 1991
Days to Decision 85 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 140d · This submission: 85d
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 K911450.
MODIFICATION PURITAN BENETT COMPANION 2801 VOL VEN
K915312 · Puritan Bennett Corp. · Jul 1992
HAYEK OSCILLATOR, MODIFICATION
K921726 · Respironics, Inc. · Apr 1992
NARKOMED AV-E VENTILATOR
K912533 · Draeger Medical, Inc. · Jul 1991
OHMEDA 7810 ANESTHESIA VENTILATOR
K910847 · Ohmeda Medical · May 1991
7200AE MICROPROCESSOR VENTILATOR W/ENHANCED HARD.
K902506 · Puritan Bennett Corp. · Jan 1991
OHMEDA 7800 ANESTHESIA VENTILATOR SOFTWARE UPDATE
K902084 · Ohmeda Medical · Oct 1990