510(k) · Cleared
ClearedApex Medical Wizard Series Cpap Mask
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 6, 2011 as substantially equivalent to K000705 (Respironics, Inc., 2000) and 3 other predicates after a 191-day review. Its family tree reaches back 3 generations to 1983. 3 later devices descend from it.
- Decided
- May 6, 2011
- Review
- 191 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K833786 (1983). 8 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK833786 Microprocessor Ventilator 7200Puritan Bennett Corp. · 1983
- 2 generations backK951264 Bipap Model S/T-DRespironics, Inc. · 1996
- 1 generation backK991648 Reusable Contour II Nasal MaskRespironics, Inc. · 1999
- This deviceK103174 Apex Medical Wizard Series Cpap MaskApex Medical Corp. · 2011
- Descendant · cites it directly · 1 of its ownK182394 WiZARD 310/320 Series CPAP MaskApex Medical Corp. · 2019
- Descendant · 2 generations on · 0 of its ownK243023 WiZARD 520 Full Face MaskWellell, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK193206 WiZARD 510 Nasal MaskApex Medical Corp. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K833786 | Microprocessor Ventilator 7200 | Puritan Bennett Corp. | 1983 | — |
| −2 | K951264 | Bipap Model S/T-D | Respironics, Inc. | 1996 | — |
| −1 | K991648 | Reusable Contour II Nasal Mask | Respironics, Inc. | 1999 | — |
| 0 (this device) | K103174 | Apex Medical Wizard Series Cpap Mask | Apex Medical Corp. | 2011 | — |
| +1 | K182394 | WiZARD 310/320 Series CPAP Mask | Apex Medical Corp. | 2019 | — |
| +2 | K243023 | WiZARD 520 Full Face Mask | Wellell, Inc. | 2025 | — |
| +1 | K193206 | WiZARD 510 Nasal Mask | Apex Medical Corp. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K000705 | Respironics Silhouette Nasal Mask, Models 1003224 and 1003223Summary page 1…WiZARD 220 Full Face Mask DviceRespironics ComfortSelect Nasal CPAP Prediate DviceMask Prediate (K000705, K991648) Respironics ComfortFull 2 Full Face CPAP Mask (K002465, K961915)… | 2000 |
| * | K991648 | Reusable Contour II Nasal MaskSummary page 1…WiZARD 220 Full Face Mask DviceRespironics ComfortSelect Nasal CPAP Prediate DviceMask Prediate (K000705, K991648) Respironics ComfortFull 2 Full Face CPAP Mask (K002465, K961915)… | 1999 |
| * | K002465 | Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876Summary page 1…DviceMask Prediate (K000705, K991648) Respironics ComfortFull 2 Full Face CPAP Mask (K002465, K961915) New device Reason for submission: Intended Usellndications for use… | 2000 |
| * | K961915 | Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, LargeSummary page 1…iceMask Prediate (K000705, K991648) Respironics ComfortFull 2 Full Face CPAP Mask (K002465, K961915) New device Reason for submission: Intended Usellndications for use… | 1996 |
What descends from it? (3)
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 28 years and passes through 3 companies; a new generation was cleared every 11.9 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K182394 (Apex Medical Corp., 2019) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K000705.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
WIZARD 210/220 series OPAP Mask is intended to provide an interface for Continuous Positive Airway Pressure (OPAP) or bi-level therapy. These masks are intended for single-patient reuse in the home and multi-patient, multi-use in the hospital environment. These masks are to be used on patients greater than 30 kg for whom positive airway pressure (CRAP or bi-level system) has been prescribed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103174 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103174: Apex Medical Wizard Series Cpap Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103174
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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