Cleared Traditional

K024322 - EMBLA N7000

K024322 is an FDA 510(k) clearance for EMBLA N7000, manufactured by Medcare Flaga. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K024322 · Medcare Flaga · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
305d
Days
Class 2
Risk

K024322 is an FDA 510(k) clearance for the EMBLA N7000. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Medcare Flaga (Battle Creek, US). The FDA issued a Cleared decision on October 27, 2003 after a review of 305 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.

FDA 510(k) Submission Details - K024322

510(k) Number K024322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2002
Decision Date October 27, 2003
Days to Decision 305 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
165d slower than avg
Panel avg: 140d · This submission: 305d
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 164
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K024322.
STARDUST II, MODEL 1011176
K021845 · Respironics, Inc. · May 2004
DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR
K040069 · Dymedix, Inc. · May 2004
COMPUMEDICS SUMMIT IP
K040194 · Compumedics USA, Ltd. · Apr 2004
APLAB, MODEL 801D0030
K030379 · Sector Medical Corp. · Aug 2003
MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM
K022506 · Widemed, Ltd. · May 2003
APNEACHECK
K022294 · Im Systems · Apr 2003
K024322 · EMBLA N7000
Download PDF FDA Summary Medcare Flaga