Cleared Traditional

K973920 - STARDUST

K973920 is an FDA 510(k) clearance for STARDUST, manufactured by Respironics, Inc.. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K973920 · Respironics, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
211d
Days
Class 2
Risk

K973920 is an FDA 510(k) clearance for the STARDUST. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Respironics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on May 14, 1998 after a review of 211 days - an extended review 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: 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.

View all Respironics, Inc. devices

FDA 510(k) Submission Details - K973920

510(k) Number K973920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1997
Decision Date May 14, 1998
Days to Decision 211 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
71d slower than avg
Panel avg: 140d · This submission: 211d
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 62
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K973920.
APNOESCREEN PRO, ALPHA SCREEN PRO
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SUZANNE
K990565 · Nellcor Puritan Bennett, Inc. · Aug 1999
SMARTRECORDER, MODEL 2500
K990199 · Respironics, Inc. · Apr 1999
SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER
K971501 · Bio-Logic Systems Corp. · Oct 1997
SLEEPWIZARD
K964494 · Nellcor Puritan Bennett, Inc. · Feb 1997
BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER
K962103 · Bio-Logic Systems Corp. · Aug 1996