510(k) · Cleared
ClearedPrestige Cpap Flow Generator with Prestige Humidifier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed, Ltd. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Jul 20, 2006 as substantially equivalent to K013909 (Resmed Corp, 2002) and 1 other predicate after an 80-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Jul 20, 2006
- Review
- 80 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K971260 (1997). 7 ancestors in all, the oldest K930656 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 3 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 2 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 1 generation backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- This deviceK061200 Prestige Cpap Flow Generator with Prestige HumidifierResmed, Ltd. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −3 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −2 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −1 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| 0 (this device) | K061200 | Prestige Cpap Flow Generator with Prestige Humidifier | Resmed, Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 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? (2)
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 |
|---|---|---|---|
| * | K013909 | S7 Elite CP AP SystemSummary page 1…Name Non continuous ventilator (IPPB). Proprietary Name PRESTIGE CPAP System Predicate Device(s) S8 Prime (K(013909) 87 Elite (K033841) Reason for submission New Device Intended for Use Th… | 2002 |
| * | K033841 | Resmed S8 Prime Cpap SystemSummary page 1…. Proprietary Name PRESTIGE CPAP System Predicate Device(s) S8 Prime (K(013909) 87 Elite (K033841) Reason for submission New Device Intended for Use The PRESTFIGE CPAP system is indicated for the treatment of… | 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 9 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 6 other devices also cite its predicate K013909.
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 PRESTIGE CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg). It is intended for use at home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061200 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061200: Prestige Cpap Flow Generator with Prestige Humidifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061200
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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