Cleared Traditional

K921926 - JET VENTILATOR/JETTING DEVICE

K921926 is an FDA 510(k) clearance for JET VENTILATOR/JETTING DEVICE, manufactured by Anesthesia Assoc., Inc.. The device is a Class 2 Anesthesiology device with 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.

FDA 510(k) Submission Details - K921926

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.

BTL Device Classification - Class 2, Special Controls

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 83
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K921926.
LSPI AUTOMATIC VENTILATOR
K932200 · Life Support Products, Inc. · Nov 1993
FLYNNR GENESIS II A/C, A/O AND IDLH
K932170 · O-Two Systems Intl., Inc. · Oct 1993
OXYGEN POWERED RESUSCITATOR FOR CPR
K920910 · J. H. Emerson Co. · Jan 1993
SPIROS
K915564 · Life Support Products, Inc. · Jan 1992
AMBU MATIC AUTOMATIC RESUSCITATOR
K904920 · Ambu, Inc. · May 1991
POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE
K905697 · Impact Instrumentation, Inc. · Dec 1990