Cleared Special

K053486 - TREND 200 CPAP DEVICE, MODEL 5CP201 (FDA 510(k) Clearance)

Also includes:
TRENDSET PC SOFTWARE, MODEL TRENDSET

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K053486 · Hoffrichter GmbH · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
20d
Days
Class 2
Risk

K053486 is an FDA 510(k) clearance for the TREND 200 CPAP DEVICE, MODEL 5CP201. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Hoffrichter GmbH (Egale, US). The FDA issued a Cleared decision on January 4, 2006 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hoffrichter GmbH devices

Submission Details

510(k) Number K053486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2005
Decision Date January 04, 2006
Days to Decision 20 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 139d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 456
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