Cleared Traditional

K021446 - OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR

K021446 is an FDA 510(k) clearance for OEMEDIC INTERNATIONAL INC. BESMED SILIC..., manufactured by Oemedic International, Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K021446 · Oemedic International, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
158d
Days
Class 2
Risk

K021446 is an FDA 510(k) clearance for the OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSC.... Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Oemedic International, Inc. (Littleton, US). The FDA issued a Cleared decision on October 11, 2002 after a review of 158 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 Oemedic International, Inc. devices

FDA 510(k) Submission Details - K021446

510(k) Number K021446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2002
Decision Date October 11, 2002
Days to Decision 158 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
18d slower than avg
Panel avg: 140d · This submission: 158d
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 K021446.
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
1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
K014115 · Portex, Inc. · Feb 2002
V*CARE MANUAL RESUSCITATOR
K012842 · Ventlab Corp. · Sep 2001