Cleared Traditional

K042745 - LIFESCREEN APNEA

K042745 is an FDA 510(k) clearance for LIFESCREEN APNEA, manufactured by Del Mar Reynolds Medical, Inc.. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K042745 · Del Mar Reynolds Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
107d
Days
Class 2
Risk

K042745 is an FDA 510(k) clearance for the LIFESCREEN APNEA. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Del Mar Reynolds Medical, Inc. (Hasbrouck Heights, US). The FDA issued a Cleared decision on January 19, 2005 after a review of 107 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K042745

510(k) Number K042745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2004
Decision Date January 19, 2005
Days to Decision 107 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 140d · This submission: 107d
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 162
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K042745.
APNEALINK, MODEL 22302
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K051313 · Salter Labs · Sep 2005
WATCH PAT 100S
K042916 · Itamar Medical · Dec 2004
UNIVERSAL XACTTRACE
K043132 · Medcare Flaga · Dec 2004
APNEA RISK EVALUATION SYSTEM (ARES)
K041662 · Advanced Brain Monitoring, Inc. · Oct 2004