Cleared Traditional

K040576 - MICROMESAM BASIC-SET

K040576 is an FDA 510(k) clearance for MICROMESAM BASIC-SET, manufactured by Map Medizintechnik Fur Arzt Und Patient GmbH. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K040576 · Map Medizintechnik Fur Arzt Und Patient GmbH · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
119d
Days
Class 2
Risk

K040576 is an FDA 510(k) clearance for the MICROMESAM BASIC-SET. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Map Medizintechnik Fur Arzt Und Patient GmbH (Poway, US). The FDA issued a Cleared decision on July 1, 2004 after a review of 119 days - within the typical 510(k) review window.

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 Map Medizintechnik Fur Arzt Und Patient GmbH devices

FDA 510(k) Submission Details - K040576

510(k) Number K040576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2004
Decision Date July 01, 2004
Days to Decision 119 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
21d faster than avg
Panel avg: 140d · This submission: 119d
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 65
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K040576.
CADWELL EASYNET NASAL PRESSURE MODULE
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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
SUZANNE
K990565 · Nellcor Puritan Bennett, Inc. · Aug 1999