Cleared Traditional

K922819 - INFANT DISPOSABLE BAG MASK RESUSCITATOR (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K922819 · Life Support Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1993
Decision
531d
Days
Class 2
Risk

K922819 is an FDA 510(k) clearance for the INFANT DISPOSABLE BAG MASK RESUSCITATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Life Support Products, Inc. (Irvine, US). The FDA issued a Cleared decision on November 24, 1993 after a review of 531 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Life Support Products, Inc. devices

Submission Details

510(k) Number K922819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1992
Decision Date November 24, 1993
Days to Decision 531 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
392d slower than avg
Panel avg: 139d · This submission: 531d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
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 - BTM Ventilator, Emergency, Manual (resuscitator)

All 208
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K922819.
The BAG manual resuscitator and accessories
K251631 · Laerdal Medical AS · Nov 2025
butterflyBVM
K243861 · Compact Medical, Inc. · Apr 2025
EOlife®
K221841 · Archeon · Mar 2023
Sotair Device
K212905 · Safe Bvm Corporation · Aug 2022
Disposable Manual Resuscitator
K210288 · Xiamen Compower Medical Tech. Co., Ltd. · Aug 2021