Cleared Traditional

MERLIN RESUSCITATOR (K031395) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

View all Merlin Medical Limited devices

Submission Details

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
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.

Device Classification

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 27
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K031395.
Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
K181583 · Flexicare Medical Limited. · Dec 2018
Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
K170663 · Foremount Enterprise Co., Ltd. · May 2018
GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
K070247 · Ohmeda Medical · Apr 2007
OHMEDA INFANT RESUSCITATION SYSTEM
K971243 · Ohmeda Medical · Dec 1997
RESPIRONICS BAGEASY ENCOR ADULT SEMI-REUSABLE
K934699 · Respironics, Inc. · Jan 1995
PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR)
K944347 · Puritan Bennett Corp. · Dec 1994