Cleared Traditional

K820132 - BABYBIRD 2 VENTILATOR

K820132 is an FDA 510(k) clearance for BABYBIRD 2 VENTILATOR, manufactured by 3M Company. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K820132 · 3M Company · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1982
Decision
10d
Days
Class 2
Risk

K820132 is an FDA 510(k) clearance for the BABYBIRD 2 VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on January 28, 1982 after a review of 10 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 3M Company devices

FDA 510(k) Submission Details - K820132

510(k) Number K820132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1982
Decision Date January 28, 1982
Days to Decision 10 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
130d faster than avg
Panel avg: 140d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

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 274
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K820132.
NEWPORT VENTILATOR MODEL E100
K820746 · Newport Medical Instruments, Inc. · Apr 1982
ANESTHESIA VENTILATOR
K820393 · Puritan Bennett Corp. · Mar 1982
JET VENTILATOR
K813254 · Healthdyne, Inc. · Feb 1982
ENGSTROM ERICA
K812642 · Lkb Instruments, Inc. · Nov 1981
HEWLETT-PACKARD VENTILATOR
K810893 · Hewlett-Packard Co. · Jun 1981
SECHRIST INFANT VENTRILATOR MODEL IV-100
K811141 · Sechrist Industries, Inc. · Jun 1981