Cleared Traditional

K031431 - BAWMED RESCUE MASK

K031431 is an FDA 510(k) clearance for BAWMED RESCUE MASK, manufactured by Bawmed UK. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 434-day FDA review.

K031431 · Bawmed UK · Anesthesiology device
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Jul 2004
Decision
434d
Days
Class 2
Risk

K031431 is an FDA 510(k) clearance for the BAWMED RESCUE MASK. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Bawmed UK (United Kingdom, GB). The FDA issued a Cleared decision on July 13, 2004 after a review of 434 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - 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 Bawmed UK devices

FDA 510(k) Submission Details - K031431

510(k) Number K031431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2003
Decision Date July 13, 2004
Days to Decision 434 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
294d slower than avg
Panel avg: 140d · This submission: 434d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBP Device Classification - Class 2, Special Controls

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
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 - CBP Valve, Non-rebreathing

All 58
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K031431.
GENUINE FIRST AID CPR MASK
K112126 · Genuine First Aid, LLC · Dec 2011
AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE
K111191 · Wet Nose Technologies, LLC · Jul 2011
DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921
K052743 · Dynarex Corp. · Dec 2005
PRESSURE MANIFOLD, MODEL BC 110
K040366 · Fisher &Paykel Healthcare , Ltd. · Mar 2004
MODIFICATION TO HIOX
K030943 · Sensor Medics Corp. · Apr 2003
HI-OX
K020665 · Sensor Medics Corp. · Jul 2002