Cleared Traditional

K990199 - SMARTRECORDER

K990199 is an FDA 510(k) clearance for SMARTRECORDER, 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 88-day FDA review.

K990199 · Respironics, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
88d
Days
Class 2
Risk

K990199 is an FDA 510(k) clearance for the SMARTRECORDER, MODEL 2500. 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 April 19, 1999 after a review of 88 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 Respironics, Inc. devices

FDA 510(k) Submission Details - K990199

510(k) Number K990199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1999
Decision Date April 19, 1999
Days to Decision 88 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
52d faster than avg
Panel avg: 140d · This submission: 88d
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 K990199.
STARDUST II, MODEL 1011176
K021845 · Respironics, Inc. · May 2004
APNOESCREEN PRO, ALPHA SCREEN PRO
K000396 · Erich Jaeger, Inc. · Dec 2000
SUZANNE
K990565 · Nellcor Puritan Bennett, Inc. · Aug 1999
STARDUST
K973920 · Respironics, Inc. · May 1998
SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER
K971501 · Bio-Logic Systems Corp. · Oct 1997
SLEEPWIZARD
K964494 · Nellcor Puritan Bennett, Inc. · Feb 1997