510(k) · Cleared
ClearedK Series Cpap Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curative Medical, Inc. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Mar 13, 2013 as substantially equivalent to K120285 (Curative Medical, Inc., 2012) after an 85-day review. Its family tree reaches back 7 generations to 1996. 2 later devices descend from it.
- Decided
- Mar 13, 2013
- Review
- 85 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K953930 (1996). 11 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 6 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 5 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 4 generations backK021861 Remstar Pro with C-Flex Cpap SystemRespironics, Inc. · 2002 · Recalled
- 3 generations backK052110 M-Series Pro Cpap SytemRespironics, Inc. · 2005 · Recalled
- 2 generations backK072996 Remstar Pro M-Series Cpap & Heated Humidifier SystemRespironics, Inc. · 2007 · Recalled
- 1 generation backK120285 K Series Cpap System with Heated HumidiferCurative Medical, Inc. · 2012
- This deviceK123897 K Series Cpap SystemsCurative Medical, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK130828 K Series Cpap SystemsCurative Medical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK131702 K Series Cpap SystemsCurative Medical, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −6 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −5 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −4 | K021861 | Remstar Pro with C-Flex Cpap System | Respironics, Inc. | 2002 | 1 |
| −3 | K052110 | M-Series Pro Cpap Sytem | Respironics, Inc. | 2005 | 15 |
| −2 | K072996 | Remstar Pro M-Series Cpap & Heated Humidifier System | Respironics, Inc. | 2007 | 1 |
| −1 | K120285 | K Series Cpap System with Heated Humidifer | Curative Medical, Inc. | 2012 | — |
| 0 (this device) | K123897 | K Series Cpap Systems | Curative Medical, Inc. | 2013 | — |
| +1 | K130828 | K Series Cpap Systems | Curative Medical, Inc. | 2014 | — |
| +1 | K131702 | K Series Cpap Systems | Curative Medical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K120285 | K Series Cpap System with Heated HumidiferSummary page 1…vice Classification Non-continuous ventilator (BZD) Name: 21 CFR 868.5905 Predicate Devices: K Series CPAP System (K1 20285) Date of Preparation: February 6, 2013 Device Description: The K Series OPAP systems are used on adult patients… | 2012 |
What descends from it? (2)
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 17 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- 6 of the 11 ancestors have a recall of any class.
- Of its descendants, K130828 (Curative Medical, Inc., 2014) has gone furthest, with 0 descendants of its own.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 K Series CPAP System, Is designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing >30 kg.
It Is intended to be used In the home or hospltailinstitutlonal environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123897 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123897: K Series Cpap Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123897
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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