Cleared Traditional

K083874 - GALAXY

K083874 is an FDA 510(k) clearance for GALAXY, manufactured by Respironics Inc., Sleep & Home Respiratory Group. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K083874 · Respironics Inc., Sleep & Home Respiratory Group · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
28d
Days
Class 2
Risk

K083874 is an FDA 510(k) clearance for the GALAXY. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Respironics Inc., Sleep & Home Respiratory Group (Murrysville, US). The FDA issued a Cleared decision on January 26, 2009 after a review of 28 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.

FDA 510(k) Submission Details - K083874

510(k) Number K083874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2008
Decision Date January 26, 2009
Days to Decision 28 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 140d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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All 162
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