510(k) · Cleared
ClearedSleepstyle 200 Auto Series HC254
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Healthcare, Ltd. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Sep 12, 2008 as substantially equivalent to K040941 (Fisher & Paykel Healthcare, Ltd., 2004) after a 154-day review. Its family tree reaches back 4 generations to 1995. 4 later devices descend from it.
- Decided
- Sep 12, 2008
- Review
- 154 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K952292 (1995). 7 ancestors in all, the oldest K915460 (1993). 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- 3 generations backK961626 Solo Cpap SystemRespironics, Inc. · 1996
- 2 generations backK973161 Cpap Humidifier (HC 200)Fisher & Paykel Electronics, Ltd. · 1998
- 1 generation backK040941 Cpap Humidifier, Model HC234 (and Related Accessories)Fisher & Paykel Healthcare, Ltd. · 2004
- This deviceK081029 Sleepstyle 200 Auto Series HC254Fisher & Paykel Healthcare, Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK110316 Infosend GSMFisher & Paykel Healthcare, Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK094040 F&P Icon Series CpapFisher & Paykel Healthcare, Ltd. · 2010 · Recalled
- Descendant · 2 generations on · 0 of its ownK173193 F&P SleepStyleFisher & Paykel Healthcare, Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK161686 F&P InfoSmartFisher & Paykel Healthcare, Ltd. · 2017
Most influential descendants
Showing 4 of 4 · See all- K110316Infosend GSMFisher & Paykel Healthcare, Ltd. · 2011 · cites it directly1descendant
- K094040F&P Icon Series CpapFisher & Paykel Healthcare, Ltd. · 2010 · cites it directly1descendant
- K173193F&P SleepStyleFisher & Paykel Healthcare, Ltd. · 2018 · 2 generations on0descendants
- K161686F&P InfoSmartFisher & Paykel Healthcare, Ltd. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K952292 | Puritan-Bennett Companion Nasal Cpap System | Puritan Bennett Corp. | 1995 | — |
| −3 | K961626 | Solo Cpap System | Respironics, Inc. | 1996 | — |
| −2 | K973161 | Cpap Humidifier (HC 200) | Fisher & Paykel Electronics, Ltd. | 1998 | — |
| −1 | K040941 | Cpap Humidifier, Model HC234 (and Related Accessories) | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| 0 (this device) | K081029 | Sleepstyle 200 Auto Series HC254 | Fisher & Paykel Healthcare, Ltd. | 2008 | — |
| +1 | K110316 | Infosend GSM | Fisher & Paykel Healthcare, Ltd. | 2011 | — |
| +1 | K094040 | F&P Icon Series Cpap | Fisher & Paykel Healthcare, Ltd. | 2010 | 1 |
| +2 | K173193 | F&P SleepStyle | Fisher & Paykel Healthcare, Ltd. | 2018 | — |
| +2 | K161686 | F&P InfoSmart | Fisher & Paykel Healthcare, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K040941 | Cpap Humidifier, Model HC234 (and Related Accessories)Summary page 1…Common name Auto CPAP Humidifier Classification Non continuous ventilator IPPB, Class II name (21 CFR § 868.5905, product code BZD) Predicate K040941 Fisher & Paykel Healthcare HC234 CPAP Humidifier devices Establishment 9611451 Registration… | 2004 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K110316 (Fisher & Paykel Healthcare, Ltd., 2011) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K040941.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 Sleepstyle TM 200 Auto Series HC254 is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081029 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081029: Sleepstyle 200 Auto Series HC254.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081029
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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