510(k) · Cleared
ClearedSapphire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Jan 8, 2016 as substantially equivalent to K140054 (Resmed, Ltd., 2014) and 1 other predicate after a 141-day review. Its family tree reaches back 10 generations to 1997. 4 later devices descend from it.
- Decided
- Jan 8, 2016
- Review
- 141 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K971260 (1997). 51 ancestors in all, the oldest K914085 (1991). 4 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 6 generations between
- 3 generations backK093684 Easycare OnlineResmed, Ltd. · 2010
- 2 generations backK123557 Easycare OnlineResmed, Ltd. · 2013
- 1 generation backK132371 Easycare OnlineResmed, Ltd. · 2013
- This deviceK152356 SapphireRespironics, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK181053 Care OrchestratorRespironics, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK242485 EveryWareBreas Medical AB · 2025
- Descendant · 2 generations on · 0 of its ownK201439 Ventilator, Non-continuous (Respirator)Respironics, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK183226 Care Orchestrator EssenceRespironics, Inc. · 2019
Show all 10 generations
- Root · 10 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 9 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 8 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 7 generations backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- 6 generations backK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- 5 generations backK050775 ResscanResmed, Ltd. · 2005
- 4 generations backK082983 Resscan-ProResmed, Ltd. · 2009
- 3 generations backK093684 Easycare OnlineResmed, Ltd. · 2010
- 2 generations backK123557 Easycare OnlineResmed, Ltd. · 2013
- 1 generation backK132371 Easycare OnlineResmed, Ltd. · 2013
- This deviceK152356 SapphireRespironics, Inc. · 2016
Most influential descendants
Showing 4 of 4 · See all- K181053Care OrchestratorRespironics, Inc. · 2019 · cites it directly1descendant
- K242485EveryWareBreas Medical AB · 2025 · cites it directly0descendants
- K201439Ventilator, Non-continuous (Respirator)Respironics, Inc. · 2020 · 2 generations on0descendants
- K183226Care Orchestrator EssenceRespironics, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −9 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −8 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −7 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| −6 | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | 1 |
| −5 | K050775 | Resscan | Resmed, Ltd. | 2005 | — |
| −4 | K082983 | Resscan-Pro | Resmed, Ltd. | 2009 | — |
| −3 | K093684 | Easycare Online | Resmed, Ltd. | 2010 | — |
| −2 | K123557 | Easycare Online | Resmed, Ltd. | 2013 | — |
| −1 | K132371 | Easycare Online | Resmed, Ltd. | 2013 | — |
| 0 (this device) | K152356 | Sapphire | Respironics, Inc. | 2016 | — |
| +1 | K181053 | Care Orchestrator | Respironics, Inc. | 2019 | — |
| +1 | K242485 | EveryWare | Breas Medical AB | 2025 | — |
| +2 | K201439 | Ventilator, Non-continuous (Respirator) | Respironics, Inc. | 2020 | — |
| +1 | K183226 | Care Orchestrator Essence | Respironics, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K140054 | RescanSummary page 4…Continuous ventilator (21 CFR 868.5895, Product Codes MNS, MNT, CBK, NOU) III. Legally Marketed Predicate Devices K140054 ResScan, ResMed LTD. K132371 EasyCare Online, ResMed LTD. IV. Device Description Sapphire is a web application… | 2014 |
| * | K132371 | Easycare OnlineSummary page 4….5895, Product Codes MNS, MNT, CBK, NOU) III. Legally Marketed Predicate Devices K140054 ResScan, ResMed LTD. K132371 EasyCare Online, ResMed LTD. IV. Device Description Sapphire is a web application that is used to manage patients utilizi… | 2013 |
What descends from it? (4)
3 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 19 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 51 ancestors have a recall of any class.
- Of its descendants, K181053 (Respironics, Inc., 2019) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K140054.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Sapphire is intended to support clinicians by tracking data on patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. Sapphire provides remote patient data collection & viewing and is intended to be used by healthcare representatives (e.g., Physicians, Clinicians, Durable Medical Equipment providers) in conjunction with compatible non-life support therapy devices to adjust prescription and/or performance settings. Sapphire allows read-only access to patients. Sapphire is intended to be used in hospital, institutional, provider, and home care settings.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152356: Sapphire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152356
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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