Cleared Traditional

K021328 - SMART BAG MO

K021328 is an FDA 510(k) clearance for SMART BAG MO, manufactured by O-Two Systems International, Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 426-day FDA review.

K021328 · O-Two Systems International, Inc. · Anesthesiology device
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Jun 2003
Decision
426d
Days
Class 2
Risk

K021328 is an FDA 510(k) clearance for the SMART BAG MO. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by O-Two Systems International, Inc. (Mississauga, CA). The FDA issued a Cleared decision on June 26, 2003 after a review of 426 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 O-Two Systems International, Inc. devices

FDA 510(k) Submission Details - K021328

510(k) Number K021328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2002
Decision Date June 26, 2003
Days to Decision 426 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
286d slower than avg
Panel avg: 140d · This submission: 426d
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 126
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K021328.
AMBU MARK IV BABY RESUSCITATOR
K053142 · Ambu A/S · Dec 2005
AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR
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AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS
K042843 · Ambu, Inc. · Nov 2004
1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR
K023793 · Portex, Inc. · Feb 2003
NELLCOR INDGO MANUAL RESUSCITATOR
K023494 · Nellcor Puritan Bennett, Inc. · Feb 2003
PMX DISPOSABLE BAG MASK RESUSCITATOR
K014071 · Allied Healthcare Products, Inc. · Oct 2002