Hoffrichter Trend 110 CPAP Device with Aquatrend III CPAP Humidifier Accessory
510(k) K041035
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK041035 | Date9 Jun 2004 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Full name
- Hoffrichter Trend 110 Cpap Device with Aquatrend III Cpap Humidifier Accessory for Trend
- 510(k) Number
- FDA Product Code
- BZD
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5905
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Hoffrichter Trend 110 CPAP Device is classified as a Ventilator, Non-Continuous (Respirator) and is designed to provide continuous positive airway pressure (CPAP) therapy. It delivers controlled airflow to maintain open airways, primarily used in the management of sleep-related breathing disorders such as obstructive sleep apnea. The device operates in conjunction with the Aquatrend III CPAP Humidifier Accessory, which enhances therapy by adding moisture to the airflow for patient comfort.
This device is intended for use in clinical settings, including hospitals and sleep laboratories, and is supplied as a reusable medical device. It has been authorized under FDA 510K clearance and complies with the Medical Device Directive (MDD). The Trend 110 is regulated under classification II, with specific registration and FEI numbers listed in the administrative records. The device is not single-use and requires proper maintenance and cleaning as per manufacturer guidelines to ensure safety and functionality.
Other devices from HOFFRICHTER GmbH
Questions
AI-generated answers, 18 Sep 2026
What clinical setting is the Hoffrichter Trend 110 CPAP Device intended for, and how does it differ from home-use devices?
The Hoffrichter Trend 110 CPAP Device is specifically designed for clinical settings such as hospitals and sleep laboratories. Unlike many home-use CPAP devices, it is a reusable medical device intended for professional use in controlled environments where patient monitoring and maintenance can be closely managed. Its regulatory classification as a Ventilator, Non-Continuous (Respirator) under FDA 510K clearance and MDD compliance further supports its use in clinical care rather than consumer settings.
Is the Hoffrichter Trend 110 CPAP Device single-use or reusable, and what maintenance is required?
The Hoffrichter Trend 110 CPAP Device is a reusable medical device, not intended for single-use. Proper maintenance and cleaning are required as per the manufacturer’s guidelines to ensure safety and functionality. This includes regular disinfection and upkeep to maintain hygiene standards in clinical environments.
What is the role of the Aquatrend III CPAP Humidifier Accessory in this device, and is it included in the standard supply?
The Aquatrend III CPAP Humidifier Accessory enhances therapy by adding moisture to the airflow delivered by the Hoffrichter Trend 110 CPAP Device, improving patient comfort. While the device is designed to operate with this accessory, the data does not specify whether it is included in the standard supply—purchasers should confirm this with the manufacturer or distributor.
What regulatory pathways does the Hoffrichter Trend 110 CPAP Device follow, and how does this affect its use?
The Hoffrichter Trend 110 CPAP Device has been authorized under FDA 510K clearance and complies with the Medical Device Directive (MDD), indicating it meets stringent regulatory standards for safety and performance. Its classification as a Class II device under FDA regulations ensures it undergoes rigorous review, including registration and listing under specific FEI numbers. This regulatory route confirms its suitability for clinical use in hospitals and sleep labs, where compliance with medical standards is critical.