Cleared Traditional

K921926 - JET VENTILATOR/JETTING DEVICE

K921926 is the FDA 510(k) clearance for JET VENTILATOR/JETTING DEVICE by Anesthesia Assoc., Inc.. It is a Class 2 Anesthesiology device (product code BTL) cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K921926 · Anesthesia Assoc., Inc. · Anesthesiology device
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Oct 1992
Decision
172d
Days
Class 2
Risk

K921926 is an FDA 510(k) clearance for the JET VENTILATOR/JETTING DEVICE. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Anesthesia Assoc., Inc. (San Marcos, US). The FDA issued a Cleared decision on October 13, 1992 after a review of 172 days - an extended review cycle.

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 Anesthesia Assoc., Inc. devices

Submission Details

510(k) Number K921926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1992
Decision Date October 13, 1992
Days to Decision 172 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
32d slower than avg
Panel avg: 140d · This submission: 172d
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 K921926.
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