Cleared Traditional

K944397 - BNOS MICROVENT

K944397 is the FDA 510(k) clearance for BNOS MICROVENT by Racal Health & Safety, Inc.. It is a Class 2 Anesthesiology device (product code BTL) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K944397 · Racal Health & Safety, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
145d
Days
Class 2
Risk

K944397 is an FDA 510(k) clearance for the BNOS MICROVENT, MODEL AC AND MODEL AO. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Racal Health & Safety, Inc. (Frederick, US). The FDA issued a Cleared decision on January 31, 1995 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5925 - 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 Racal Health & Safety, Inc. devices

Submission Details

510(k) Number K944397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received September 08, 1994
Decision Date January 31, 1995
Days to Decision 145 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 140d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTL Ventilator, Emergency, Powered (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5925
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 - BTL Ventilator, Emergency, Powered (resuscitator)

All 8
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K944397.
Puffin Lite Infant Resuscitation System
K182956 · International Biomedical · Jan 2019
SafeT T-Piece Resuscitator
K173373 · Ventlab, LLC · Nov 2018
GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
K070210 · Ohmeda Medical · Apr 2007
OHMEDA - LOGIC 07A TRANSPORT VENTILATOR
K901846 · Ohmeda Medical · Aug 1990