510(k) · Cleared
ClearedCM 5000 Monitor Airway Pressure
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canadian Monaghan, Ltd. · CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Cleared on Apr 8, 1987 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Apr 8, 1987
- Review
- 21 days
- Class
- Class II
- Product code
- CAP
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK871083 CM 5000 Monitor Airway PressureCanadian Monaghan, Ltd. · 1987
- Descendant · cites it directly · 6 of its ownK992101 Criterion 40 or PM 40Caradyne, Ltd. · 2000
- Descendant · 2 generations on · 2 of its ownK221734 Maxtec MaxO2 ME+pMaxtec, LLC · 2023
- Descendant · 3 generations on · 0 of its ownK251245 OxyMinder Pro (10310)Bio-Med Device, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK231895 Maxtec MaxBlend2+pMaxtec, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK182292 VORTRAN APM-PlusVortran Medical Technology 1, Inc. · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K992101Criterion 40 or PM 40Caradyne, Ltd. · 2000 · cites it directly6descendants
- K221734Maxtec MaxO2 ME+pMaxtec, LLC · 2023 · 2 generations on2descendants
- K251245OxyMinder Pro (10310)Bio-Med Device, Inc. · 2025 · 3 generations on0descendants
- K231895Maxtec MaxBlend2+pMaxtec, LLC · 2023 · 3 generations on0descendants
- K182292VORTRAN APM-PlusVortran Medical Technology 1, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K871083 | CM 5000 Monitor Airway Pressure | Canadian Monaghan, Ltd. | 1987 | — |
| +1 | K992101 | Criterion 40 or PM 40 | Caradyne, Ltd. | 2000 | — |
| +2 | K221734 | Maxtec MaxO2 ME+p | Maxtec, LLC | 2023 | — |
| +3 | K251245 | OxyMinder Pro (10310) | Bio-Med Device, Inc. | 2025 | — |
| +3 | K231895 | Maxtec MaxBlend2+p | Maxtec, LLC | 2023 | — |
| +2 | K182292 | VORTRAN APM-Plus | Vortran Medical Technology 1, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CAP? 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 CAP device
- #1 K201666 Single Use Manometerscore 0.3 · 1 generation · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992101 | Criterion 40 or PM 40 | 2000 | 6 |
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, K992101 (Caradyne, Ltd., 2000) has gone furthest, with 6 descendants of its own.
How does its category compare?
All CAP devicesCAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAP
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · CAP
Too few CAP 510(k)s in any year since 2007 to give a median.
Recalls per year · CAP
No recall names CAP since 2007.
Adverse event reports per year · CAP
2in 2025
MAUDE reports naming product code CAP, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 4 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K871083 · printed Nov 4, 2026
Cite this page
510(k) Report. “K871083: CM 5000 Monitor Airway Pressure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K871083
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026