Cleared Traditional

K000396 - APNOESCREEN PRO

K000396 is an FDA 510(k) clearance for APNOESCREEN PRO, manufactured by Erich Jaeger, Inc.. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K000396 · Erich Jaeger, Inc. · Anesthesiology device
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Dec 2000
Decision
324d
Days
Class 2
Risk

K000396 is an FDA 510(k) clearance for the APNOESCREEN PRO, ALPHA SCREEN PRO. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Erich Jaeger, Inc. (Yorba Linda, US). The FDA issued a Cleared decision on December 27, 2000 after a review of 324 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, Inc. devices

FDA 510(k) Submission Details - K000396

510(k) Number K000396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2000
Decision Date December 27, 2000
Days to Decision 324 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 140d · This submission: 324d
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 K000396.
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
SUZANNE
K990565 · Nellcor Puritan Bennett, Inc. · Aug 1999
SMARTRECORDER, MODEL 2500
K990199 · Respironics, Inc. · Apr 1999
STARDUST
K973920 · Respironics, Inc. · May 1998