510(k) Report

510(k) · Cleared

Cleared

Apex Medical XT1 Cpap, Model 9S-005

K070609510(k) SpecialCleared May 4, 200760-day reviewClass II21 CFR 868.5905

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Apex Medical Corp. · BZD Ventilator, Non-Continuous (Respirator)

Cleared on May 4, 2007 after a 60-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.

Decided
May 4, 2007
Review
60 days
Class
Class II
Product code
BZD
Recalls
None
Predicates
0

6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2013: 1 descendant cleared2012: 2 descendants cleared2014: 1 descendant cleared2015: 1 descendant cleared20052010201520202025
  1. This deviceK070609 Apex Medical XT1 Cpap, Model 9S-005Apex Medical Corp. · 2007
  2. Descendant · cites it directly · 4 of its ownK083656 Apex Medical XT Auto Cpap 9S-005200Apex Medical Corp. · 2009
  3. Descendant · 2 generations on · 2 of its ownK112079 Apex Medical XT Auto Cpap with Compliance Improvement Algorithm…Apex Medical Corp. · 2012
  4. Descendant · 2 generations on · 2 of its ownK120035 Apex Medical Ich Cpap Series (9S-007XXX)Apex Medical Corp. · 2012
  5. Descendant · 3 generations on · 1 of its ownK141522 Apex Medical Corp. Ich Cpap with Pva 9S-007XXX SeriesApex Medical Corp. · 2014
  6. Descendant · 4 generations on · 0 of its ownK150111 Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesApex Medical Corp. · 2015

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2009: 12012: 22013: 12014: 12015: 1
2009high 2 (2012) · low 0 (2010)2026

Most influential descendants

Showing 5 of 6 · 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K070609Apex Medical XT1 Cpap, Model 9S-005Apex Medical Corp.2007—
+1K083656Apex Medical XT Auto Cpap 9S-005200Apex Medical Corp.2009—
+2K112079Apex Medical XT Auto Cpap with Compliance Improvement Algorithm 9S-005720Apex Medical Corp.2012—
+2K120035Apex Medical Ich Cpap Series (9S-007XXX)Apex Medical Corp.2012—
+3K141522Apex Medical Corp. Ich Cpap with Pva 9S-007XXX SeriesApex Medical Corp.2014—
+4K150111Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesApex Medical Corp.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201220
201310
201410
201510
FIG. 1 — Lineage of K070609, 2007–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K083656Apex Medical XT Auto Cpap 9S-005200Apex Medical Corp.20094
K130037Breathe Cpap SystemBreathe Technologies, Inc.20130

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 devices

BZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · BZD

7in 2025

2007: 212008: 172009: 232010: 122011: 232012: 212013: 232014: 142015: 112016: 122017: 52018: 52019: 62020: 62021: 62022: 42023: 52024: 102025: 72026 (partial year): 10
2007high 23 (2009) · low 4 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZD

189in 2025

2007: 83 days median2008: 108 days median2009: 90 days median2010: 122 days median2011: 125 days median2012: 133 days median2013: 127 days median2014: 172 days median2015: 224 days median2016: 217 days median2017: 221 days median2018: 280 days median2019: 231 days median2020: 137 days median2021: 192 days median2022: 253 days median2023: 204 days median2024: 132 days median2025: 189 days median2026 (partial year): 214 days median
2007high 280 (2018) · low 83 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BZD

8in 2023

2007: 292008: 22009: 12011: 12019: 4, 4 Class I2023: 8, 7 Class I2026 (partial year): 2, 2 Class I
2007high 29 (2007) · low 0 (2010)2026

Class I (13 since 2007) Class II/III not classified

Adverse event reports per year · BZD

60,279in 2025

2007: 652008: 672009: 1472010: 1432011: 1892012: 1392013: 822014: 862015: 1142016: 1182017: 1482018: 1012019: 1882020: 1262021: 6,0662022: 90,7682023: 27,9872024: 68,2622025: 60,279
2007high 90,768 (2022) · low 65 (2007)2025

MAUDE reports naming product code BZD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200721832965
200817108267
200923901147
2010121220143
2011231251189
2012211330139
201323127082
201414172086
2015112240114
2016122170118
201752210148
201852800101
201962314 (4)188
202061370126
2021619206,066
20224253090,768
202352048 (7)27,987
202410132068,262
20257189060,279
2026102142 (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.

More from Apex Medical Corp.

30 FDA decisions under this applicant name. See the company

  • K213577VenAir, Sequential Compression SystemApex Medical Corp. · 2022
  • K193206WiZARD 510 Nasal MaskApex Medical Corp. · 2020
  • K182394WiZARD 310/320 Series CPAP MaskApex Medical Corp. · 2019
  • K150111Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesApex Medical Corp. · 2015
  • K141522Apex Medical Corp. Ich Cpap with Pva 9S-007XXX SeriesApex Medical Corp. · 2014

Recent decisions in BZD

The BZD category page

  • K260251BreathCare PAP III (YH-390N)Suzhou Yuyue Medical Technology Co., Ltd. · 2026
  • K261262Altis Full Face MaskRespironics, Inc. · 2026
  • K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd. · 2026
  • K253553OrionResmed Corp · 2026
  • K254104ResScan EssentialsResmed Corp · 2026

https://510kreport.com/device/K070609 · printed Nov 3, 2026

Cite this page

510(k) Report. “K070609: Apex Medical XT1 Cpap, Model 9S-005.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070609

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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