Cleared Traditional

K021138 - SLEEPSCREEN/APNOESCREEN CARDIO

K021138 is an FDA 510(k) clearance for SLEEPSCREEN/APNOESCREEN CARDIO, manufactured by Erich Jaeger GmbH. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K021138 · Erich Jaeger GmbH · Anesthesiology device
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Feb 2003
Decision
309d
Days
Class 2
Risk

K021138 is an FDA 510(k) clearance for the SLEEPSCREEN/APNOESCREEN CARDIO. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Erich Jaeger GmbH (Yorba Linda, US). The FDA issued a Cleared decision on February 12, 2003 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Erich Jaeger GmbH devices

FDA 510(k) Submission Details - K021138

510(k) Number K021138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2002
Decision Date February 12, 2003
Days to Decision 309 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
169d slower than avg
Panel avg: 140d · This submission: 309d
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 94
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K021138.
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
APNOESCREEN PRO, ALPHA SCREEN PRO
K000396 · Erich Jaeger, Inc. · Dec 2000
SNAP MODEL 5
K992322 · Snap Laboratories, LLC · Feb 2000
SUZANNE
K990565 · Nellcor Puritan Bennett, Inc. · Aug 1999