Cleared Traditional

K061405 - APNEALINK

K061405 is an FDA 510(k) clearance for APNEALINK, manufactured by Resmed Germany, Inc.. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K061405 · Resmed Germany, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
67d
Days
Class 2
Risk

K061405 is an FDA 510(k) clearance for the APNEALINK, MODEL 22302. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Resmed Germany, Inc. (Poway, US). The FDA issued a Cleared decision on July 25, 2006 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Resmed Germany, Inc. devices

FDA 510(k) Submission Details - K061405

510(k) Number K061405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2006
Decision Date July 25, 2006
Days to Decision 67 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 140d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNR Device Classification - Class 2, Special Controls

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 - MNR Ventilatory Effort Recorder

All 65
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K061405.
ALICE PDX
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GALAXY
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CADWELL EASYNET NASAL PRESSURE MODULE
K061705 · Cadwell Laboratories, Inc. · Nov 2006
STARDUST II
K052573 · Respironics, Inc. · Dec 2005
BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER
K051313 · Salter Labs · Sep 2005
STARDUST II, MODEL 1011176
K021845 · Respironics, Inc. · May 2004