Cleared Traditional

K014063 - TASK FORCE MONITOR 3040

K014063 is an FDA 510(k) clearance for TASK FORCE MONITOR 3040, manufactured by Cnsystems Medizintechnik GmbH. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K014063 · Cnsystems Medizintechnik GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
58d
Days
Class 2
Risk

K014063 is an FDA 510(k) clearance for the TASK FORCE MONITOR 3040. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Cnsystems Medizintechnik GmbH (Europe, AT). The FDA issued a Cleared decision on February 7, 2002 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2770 - the FDA cardiovascular device oversight 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.

View all Cnsystems Medizintechnik GmbH devices

FDA 510(k) Submission Details - K014063

510(k) Number K014063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2001
Decision Date February 07, 2002
Days to Decision 58 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 125d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DSB Device Classification - Class 2, Special Controls

Product Code DSB Plethysmograph, Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
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 Cardiovascular devices follow this clearance model.

Regulatory Consultant

Tuv Product Service, Inc.
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DSB Plethysmograph, Impedance

All 62
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K014063.
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