510(k) · Cleared
ClearedTrend 200 Cpap Device, Model 5CP201; Trendset PC Software, Model Trendset
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hoffrichter GmbH · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Jan 4, 2006 as substantially equivalent to K041035 (Hoffrichter GmbH, 2004) after a 20-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Jan 4, 2006
- Review
- 20 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K952292 (1995). 9 ancestors in all, the oldest K915460 (1993). No later device cites it as a predicate yet.
- Root · 5 generations backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- 4 generations backK961626 Solo Cpap SystemRespironics, Inc. · 1996
- 3 generations backK973161 Cpap Humidifier (HC 200)Fisher & Paykel Electronics, Ltd. · 1998
- 2 generations backK014074 Hoffrichter Vector, Vector Plus, Vector BI-Vevel, Vector BI-Level…Hoffrichter GmbH · 2003
- 1 generation backK041035 Hoffrichter Trend 110 Cpap Device with Aquatrend Iii Cpap Humidifier…Hoffrichter GmbH · 2004
- This deviceK053486 Trend 200 Cpap Device, Model 5CP201; Trendset PC Software, Model…Hoffrichter GmbH · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K952292 | Puritan-Bennett Companion Nasal Cpap System | Puritan Bennett Corp. | 1995 | — |
| −4 | K961626 | Solo Cpap System | Respironics, Inc. | 1996 | — |
| −3 | K973161 | Cpap Humidifier (HC 200) | Fisher & Paykel Electronics, Ltd. | 1998 | — |
| −2 | K014074 | Hoffrichter Vector, Vector Plus, Vector BI-Vevel, Vector BI-Level Plus… | Hoffrichter GmbH | 2003 | — |
| −1 | K041035 | Hoffrichter Trend 110 Cpap Device with Aquatrend Iii Cpap Humidifier Accessory… | Hoffrichter GmbH | 2004 | — |
| 0 (this device) | K053486 | Trend 200 Cpap Device, Model 5CP201; Trendset PC Software, Model Trendset | Hoffrichter GmbH | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZD device
- #1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041035 | Hoffrichter Trend 110 Cpap Device with Aquatrend Iii Cpap Humidifier Accessory for TrendSummary page 1…BZD, 21 CFR §868.5905 Class: Class II (3) Predicate Device(s): - TREND 110 CPAP Device (K041035) Reason for Submission: Device modification to TREND 110 (4) Description of Devic… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 2025
MAUDE reports naming product code BZD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 21 | 83 | 29 | 65 |
| 2008 | 17 | 108 | 2 | 67 |
| 2009 | 23 | 90 | 1 | 147 |
| 2010 | 12 | 122 | 0 | 143 |
| 2011 | 23 | 125 | 1 | 189 |
| 2012 | 21 | 133 | 0 | 139 |
| 2013 | 23 | 127 | 0 | 82 |
| 2014 | 14 | 172 | 0 | 86 |
| 2015 | 11 | 224 | 0 | 114 |
| 2016 | 12 | 217 | 0 | 118 |
| 2017 | 5 | 221 | 0 | 148 |
| 2018 | 5 | 280 | 0 | 101 |
| 2019 | 6 | 231 | 4 (4) | 188 |
| 2020 | 6 | 137 | 0 | 126 |
| 2021 | 6 | 192 | 0 | 6,066 |
| 2022 | 4 | 253 | 0 | 90,768 |
| 2023 | 5 | 204 | 8 (7) | 27,987 |
| 2024 | 10 | 132 | 0 | 68,262 |
| 2025 | 7 | 189 | 0 | 60,279 |
| 2026 | 10 | 214 | 2 (2) | — |
What is it indicated for?
The TREND 200 device is for treatment of obstructive sleep apnea (OSA) in adult patients weighing at least 30 kg. These devices are not intended for use with ventilator-dependent patients.
The TREND 200 device provides continuous positive airway pressure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053486 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053486: Trend 200 Cpap Device, Model 5CP201; Trendset PC Software, Model Trendset.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053486
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026