510(k) · Cleared
ClearedPioneer U121 Series Cpap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merits Health Products Co., Ltd. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on May 10, 2005 as substantially equivalent to K982242 (Invacare Corp., 1999) after a 308-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- May 10, 2005
- Review
- 308 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K952292 (1995). 5 ancestors in all, the oldest K930656 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- 2 generations backK961626 Solo Cpap SystemRespironics, Inc. · 1996
- 1 generation backK982242 Invacare CpapInvacare Corp. · 1999
- This deviceK041823 Pioneer U121 Series CpapMerits Health Products Co., Ltd. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952292 | Puritan-Bennett Companion Nasal Cpap System | Puritan Bennett Corp. | 1995 | — |
| −2 | K961626 | Solo Cpap System | Respironics, Inc. | 1996 | — |
| −1 | K982242 | Invacare Cpap | Invacare Corp. | 1999 | — |
| 0 (this device) | K041823 | Pioneer U121 Series Cpap | Merits Health Products Co., Ltd. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 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 |
|---|---|---|---|
| * | K982242 | Invacare CpapSummary page 1…omparison to Currently Marketed Devices The Merits Health Products Pioneer U121 Series CPAP are substantially equivalent to the Invacare Polaris CPAP System (K982242). 9.5 Device Description The Pioneer U121 Series CPAP operates using standard AC Power from a wall outlet.… | 1999 |
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 10 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K982242.
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 Pioneer U121 Series CPAP are indicated for treating the adult, suffering from Obstructive Sleep Apnea (OSA), in the home by delivering continuous positive air pressure to the upper airway. The devices are not intended for life support nor do they provide any patient monitoring capabilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041823 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041823: Pioneer U121 Series Cpap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041823
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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