510(k) · Cleared
ClearedApex Medical Ich Cpap Series (9S-007XXX)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apex Medical Corp. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on May 16, 2012 as substantially equivalent to K083656 (Apex Medical Corp., 2009) and 1 other predicate after a 133-day review. Its family tree reaches back 4 generations to 1997. 2 later devices descend from it.
- Decided
- May 16, 2012
- Review
- 133 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K971260 (1997). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 3 generations backK013843 Autoset Spirit Cpap SystemResmed Corp · 2002
- 2 generations backK032480 Autoset Spirit SystemResmed, Ltd. · 2003
- 1 generation backK083656 Apex Medical XT Auto Cpap 9S-005200Apex Medical Corp. · 2009
- This deviceK120035 Apex Medical Ich Cpap Series (9S-007XXX)Apex Medical Corp. · 2012
- Descendant · cites it directly · 1 of its ownK141522 Apex Medical Corp. Ich Cpap with Pva 9S-007XXX SeriesApex Medical Corp. · 2014
- Descendant · 2 generations on · 0 of its ownK150111 Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesApex Medical Corp. · 2015
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 |
|---|---|---|---|---|---|
| −4 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −3 | K013843 | Autoset Spirit Cpap System | Resmed Corp | 2002 | — |
| −2 | K032480 | Autoset Spirit System | Resmed, Ltd. | 2003 | — |
| −1 | K083656 | Apex Medical XT Auto Cpap 9S-005200 | Apex Medical Corp. | 2009 | — |
| 0 (this device) | K120035 | Apex Medical Ich Cpap Series (9S-007XXX) | Apex Medical Corp. | 2012 | — |
| +1 | K141522 | Apex Medical Corp. Ich Cpap with Pva 9S-007XXX Series | Apex Medical Corp. | 2014 | — |
| +2 | K150111 | Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series | Apex Medical Corp. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K083656 | Apex Medical XT Auto Cpap 9S-005200Summary page 1…cialty: Anesthesiology Product Code: 73 BZD Device Class: 11 Predicate Device APEX MEDICAL XT Auto OPAP MODEL 9S-005200 (K083656) APEX MEDICAL HumidCare Heated Humidifier MODEL 9S-004 (K062664) Reason for… | 2009 |
| * | K062664 | Humidcare Heated Humidifier, Model 9S-004Summary page 1…dicate Device APEX MEDICAL XT Auto OPAP MODEL 9S-005200 (K083656) APEX MEDICAL HumidCare Heated Humidifier MODEL 9S-004 (K062664) Reason for New Device Submission… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141522 | Apex Medical Corp. Ich Cpap with Pva 9S-007XXX Series | 2014 | 1 |
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 15 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K141522 (Apex Medical Corp., 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K083656.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult obstructive sleep apnea (OSA).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120035 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120035: Apex Medical Ich Cpap Series (9S-007XXX).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120035
Report an extraction error
Are you the manufacturer?
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