Cleared Traditional

K014071 - PMX DISPOSABLE BAG MASK RESUSCITATOR

K014071 is an FDA 510(k) clearance for PMX DISPOSABLE BAG MASK RESUSCITATOR, manufactured by Allied Healthcare Products, Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 295-day FDA review.

K014071 · Allied Healthcare Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
295d
Days
Class 2
Risk

K014071 is an FDA 510(k) clearance for the PMX DISPOSABLE BAG MASK RESUSCITATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Allied Healthcare Products, Inc. (Saint Louis, US). The FDA issued a Cleared decision on October 1, 2002 after a review of 295 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 Allied Healthcare Products, Inc. devices

FDA 510(k) Submission Details - K014071

510(k) Number K014071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2001
Decision Date October 01, 2002
Days to Decision 295 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
155d slower than avg
Panel avg: 140d · This submission: 295d
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 82
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K014071.
AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR
K042682 · Ambu, Inc. · Nov 2004
AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS
K042843 · Ambu, Inc. · Nov 2004
NELLCOR INDGO MANUAL RESUSCITATOR
K023494 · Nellcor Puritan Bennett, Inc. · Feb 2003
AMBU NEONATE SILICONE RESUSCITATOR
K993278 · Ambu, Inc. · May 2000
RUSCH MANUAL RESUSCITATOR BAG
K993194 · Rusch, Inc. · Mar 2000
DMR PLUS DISPOSABLE MANUAL RESUSCITATOR
K973419 · Nellcor Puritan Bennett, Inc. · Mar 1998