510(k) · Cleared
ClearedApex Medical Cpap RT 21XX
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 Feb 4, 2004 after a 544-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Feb 4, 2004
- Review
- 544 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK022650 Apex Medical Cpap RT 21XXApex Medical Corp. · 2004
- Descendant · cites it directly · 4 of its ownK083656 Apex Medical XT Auto Cpap 9S-005200Apex Medical Corp. · 2009
- Descendant · 2 generations on · 2 of its ownK112079 Apex Medical XT Auto Cpap with Compliance Improvement Algorithm…Apex Medical Corp. · 2012
- Descendant · 2 generations on · 2 of its ownK120035 Apex Medical Ich Cpap Series (9S-007XXX)Apex Medical Corp. · 2012
- Descendant · 3 generations on · 1 of its ownK141522 Apex Medical Corp. Ich Cpap with Pva 9S-007XXX SeriesApex Medical Corp. · 2014
- Descendant · 4 generations on · 0 of its ownK150111 Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesApex Medical Corp. · 2015
Most influential descendants
Showing 5 of 5 · See all- K083656Apex Medical XT Auto Cpap 9S-005200Apex Medical Corp. · 2009 · cites it directly4descendants
- K112079Apex Medical XT Auto Cpap with Compliance Improvement Algorithm 9S-005720Apex Medical Corp. · 2012 · 2 generations on2descendants
- K120035Apex Medical Ich Cpap Series (9S-007XXX)Apex Medical Corp. · 2012 · 2 generations on2descendants
- K141522Apex Medical Corp. Ich Cpap with Pva 9S-007XXX SeriesApex Medical Corp. · 2014 · 3 generations on1descendant
- K150111Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesApex Medical Corp. · 2015 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022650 | Apex Medical Cpap RT 21XX | Apex Medical Corp. | 2004 | — |
| +1 | K083656 | Apex Medical XT Auto Cpap 9S-005200 | Apex Medical Corp. | 2009 | — |
| +2 | K112079 | Apex Medical XT Auto Cpap with Compliance Improvement Algorithm 9S-005720 | Apex Medical Corp. | 2012 | — |
| +2 | K120035 | Apex Medical Ich Cpap Series (9S-007XXX) | Apex Medical Corp. | 2012 | — |
| +3 | K141522 | Apex Medical Corp. Ich Cpap with Pva 9S-007XXX Series | Apex Medical Corp. | 2014 | — |
| +4 | K150111 | Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series | Apex Medical Corp. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083656 | Apex Medical XT Auto Cpap 9S-005200 | 2009 | 4 |
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?
- Of its descendants, K083656 (Apex Medical Corp., 2009) has gone furthest, with 4 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.
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 510(k) statement.
https://510kreport.com/device/K022650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022650: Apex Medical Cpap RT 21XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022650
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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