Cleared Traditional

K921553 - LSPI INFANT BAG MASK

K921553 is an FDA 510(k) clearance for LSPI INFANT BAG MASK, manufactured by Life Support Products, Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K921553 · Life Support Products, Inc. · Anesthesiology device
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Oct 1992
Decision
201d
Days
Class 2
Risk

K921553 is an FDA 510(k) clearance for the LSPI INFANT BAG MASK. 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 October 19, 1992 after a review of 201 days - an extended review cycle.

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: 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 Life Support Products, Inc. devices

FDA 510(k) Submission Details - K921553

510(k) Number K921553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1992
Decision Date October 19, 1992
Days to Decision 201 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 140d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTM Device Classification - Class 2, Special Controls

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 103
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K921553.
AID, CARDIOPULMONARY RESUSCITATION
K930429 · Valley Forge Scientific Corp. · Mar 1993
SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE
K923762 · Ambu, Inc. · Feb 1993
MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)
K913714 · Life Design Systems, Inc. · Dec 1992
LSPI DISPOSABLE BAG MASK RESUSCITATOR/MODIFIED
K924217 · Life Support Products, Inc. · Sep 1992
AMBU SILICONE RESUSCITATOR, ADULT W/OPEN RESERVOIR
K924215 · Ambu, Inc. · Sep 1992
AMBU SILICONE RESUSCITATOR INFAN/CHILD W/OPEN RESO
K924216 · Ambu, Inc. · Sep 1992