Cleared Traditional

K031395 - MERLIN RESUSCITATOR

K031395 is an FDA 510(k) clearance for MERLIN RESUSCITATOR, manufactured by Merlin Medical Limited. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 441-day FDA review.

K031395 · Merlin Medical Limited · Anesthesiology device
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Jul 2004
Decision
441d
Days
Class 2
Risk

K031395 is an FDA 510(k) clearance for the MERLIN RESUSCITATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Merlin Medical Limited (United Kingdom, GB). The FDA issued a Cleared decision on July 16, 2004 after a review of 441 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.

FDA 510(k) Submission Details - K031395

510(k) Number K031395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2003
Decision Date July 16, 2004
Days to Decision 441 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
301d slower than avg
Panel avg: 140d · This submission: 441d
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 207
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K031395.
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
STURDY MANUAL RESUSCITATOR
K032596 · Sturdy Industrial Co., Ltd. · Aug 2004
BAWMED E-Z BAG RESUSCITATOR
K031434 · Bawmed UK · Feb 2004
VADI MANUAL RESUSCITATOR
K030864 · Vedi Corp. · Jan 2004
SMART BAG MO
K021328 · O-Two Systems International, Inc. · Jun 2003
K031395 · MERLIN RESUSCITATOR
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