Cleared Traditional

K041904 - COMPASS F10 SYSTEM

K041904 is an FDA 510(k) clearance for COMPASS F10 SYSTEM, 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 54-day FDA review.

K041904 · Medcare Flaga · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
54d
Days
Class 2
Risk

K041904 is an FDA 510(k) clearance for the COMPASS F10 SYSTEM. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Medcare Flaga (Reykjavik, IS). The FDA issued a Cleared decision on September 7, 2004 after a review of 54 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.

FDA 510(k) Submission Details - K041904

510(k) Number K041904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2004
Decision Date September 07, 2004
Days to Decision 54 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
86d faster than avg
Panel avg: 140d · This submission: 54d
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 K041904.
APNEA RISK EVALUATION SYSTEM (ARES)
K041662 · Advanced Brain Monitoring, Inc. · Oct 2004
SLEEPSENSE SLEEP SENSORS
K042253 · S.L.P. , Ltd. · Oct 2004
COMPASS M10 SYSTEM
K041724 · Medcare Flaga · Sep 2004
MICROMESAM BASIC-SET
K040576 · Map Medizintechnik Fur Arzt Und Patient GmbH · Jul 2004
PORTABLE SLEEP DATA RECORDER (PSDR)
K033402 · Pro-Tech Services, Inc. · Jun 2004
STARDUST II, MODEL 1011176
K021845 · Respironics, Inc. · May 2004
K041904 · COMPASS F10 SYSTEM
Download PDF FDA Summary Medcare Flaga