Cleared Abbreviated

NEONATALIE RESUSCITATOR (K132172) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K132172 · Laerdal Medical A/S · Anesthesiology device
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Jan 2015
Decision
549d
Days
Class 2
Risk

K132172 is an FDA 510(k) clearance for the NEONATALIE RESUSCITATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Laerdal Medical A/S (Stavanger, NO). The FDA issued a Cleared decision on January 15, 2015 after a review of 549 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. 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 Laerdal Medical A/S devices

Submission Details

510(k) Number K132172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2013
Decision Date January 15, 2015
Days to Decision 549 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
409d slower than avg
Panel avg: 140d · This submission: 549d
Pathway characteristics
Standards-based clearance path.

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 26
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K132172.
Disposable Manual Resuscitator
K210288 · Xiamen Compower Medical Tech. Co., Ltd. · Aug 2021
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