510(k) · Cleared
ClearedF&P SleepStyle
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 Aug 8, 2018 as substantially equivalent to K094040 (Fisher & Paykel Healthcare, Ltd., 2010) after a 310-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Aug 8, 2018
- Review
- 310 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K952292 (1995). 10 ancestors in all, the oldest K915460 (1993). No later device cites it as a predicate yet.
- Root · 6 generations backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- 5 generations backK961626 Solo Cpap SystemRespironics, Inc. · 1996
- 4 generations backK973161 Cpap Humidifier (HC 200)Fisher & Paykel Electronics, Ltd. · 1998
- 3 generations backK040941 Cpap Humidifier, Model HC234 (and Related Accessories)Fisher & Paykel Healthcare, Ltd. · 2004
- 2 generations backK041900 HC604 Cpap HumidifierFisher & Paykel Healthcare, Ltd. · 2004
- 1 generation backK094040 F&P Icon Series CpapFisher & Paykel Healthcare, Ltd. · 2010 · Recalled
- This deviceK173193 F&P SleepStyleFisher & Paykel Healthcare, Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K952292 | Puritan-Bennett Companion Nasal Cpap System | Puritan Bennett Corp. | 1995 | — |
| −5 | K961626 | Solo Cpap System | Respironics, Inc. | 1996 | — |
| −4 | K973161 | Cpap Humidifier (HC 200) | Fisher & Paykel Electronics, Ltd. | 1998 | — |
| −3 | K040941 | Cpap Humidifier, Model HC234 (and Related Accessories) | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −2 | K041900 | HC604 Cpap Humidifier | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −1 | K094040 | F&P Icon Series Cpap | Fisher & Paykel Healthcare, Ltd. | 2010 | 1 |
| 0 (this device) | K173193 | F&P SleepStyle | Fisher & Paykel Healthcare, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K094040 | F&P Icon Series CpapSummary page 4…Class II (21 CFR §868.5905) Product code BZD (Anaesthesiology) Predicate device F&P ICON (K094040) Intended Use and Indications for Use The device is for use on adult patients for the treatment of Obstructive Sleep Apnea (OS… | 2010 |
| † | K161686 | F&P InfoSmart | 2017 |
| † | K110316 | Infosend GSM | 2011 |
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 23 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 10 ancestors has a recall of any class.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 device 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/K173193 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173193: F&P SleepStyle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173193
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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