510(k) · Cleared
ClearedFamily of DIMAR DMAX NIV masks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dimar S.P.A. · CBK Ventilator, Continuous, Facility Use
Cleared on Aug 14, 2024 as substantially equivalent to K072588 (Respironics Inc., Sleep & Home Respiratory Group, 2007) and 1 other predicate after a 335-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Aug 14, 2024
- Review
- 335 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K925920 (1993). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK925920 Total Face MaskRespironics, Inc. · 1993
- 2 generations backK992969 Respironics Total Face MaskRespironics, Inc. · 1999
- 1 generation backK072588 Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2007
- This deviceK232836 Family of DIMAR DMAX NIV masksDimar S.P.A. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925920 | Total Face Mask | Respironics, Inc. | 1993 | — |
| −2 | K992969 | Respironics Total Face Mask | Respironics, Inc. | 1999 | — |
| −1 | K072588 | Performax SE Total Face Mask | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| 0 (this device) | K232836 | Family of DIMAR DMAX NIV masks | Dimar S.P.A. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 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 CBK? 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 CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 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 |
|---|---|---|---|
| * | K072588 | Performax SE Total Face MaskSummary page 5…S. market: Applicant Device Name 510(k) Number Respironics Inc. Performax SE Total Face Mask K072588 (primary predicate device) Respironics Inc. Respironics Total Face Mask K992969… | 2007 |
| * | K992969 | Respironics Total Face MaskSummary page 5…SE Total Face Mask K072588 (primary predicate device) Respironics Inc. Respironics Total Face Mask K992969 (secondary predicate device) 4. Indications for Use FAMILY OF DIMAR DIMAX NIV MASKS is intended to… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K072588.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, 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 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
FAMILY OF DIMAR DIMAX NIV MASKS is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency. For single patient use in the Hospital environment The mask is to be used…
Read the full statement (113 words)
FAMILY OF DIMAR DIMAX NIV MASKS is intended to provide a patient interface for application of noninvasive ventilation.
The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency.
For single patient use in the Hospital environment
The mask is to be used on patients who are appropriate candidates for noninvasive ventilation.
The small size is intended to be used for children (from 7 years and > 20kg) while the sizes medium/large/ extra-large/ extra-extra-large are intended to be used for adolescents or adults >30 kg
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K232836 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232836: Family of DIMAR DMAX NIV masks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232836
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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