510(k) · Cleared
ClearedCriterion 40 or PM 40
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caradyne, Ltd. · CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Cleared on Jan 6, 2000 as substantially equivalent to K871083 (Canadian Monaghan, Ltd., 1987) and 3 other predicates after a 198-day review. Its family tree reaches back 1 generation to 1987. 6 later devices descend from it.
- Decided
- Jan 6, 2000
- Review
- 198 days
- Class
- Class II
- Product code
- CAP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K871083 (1987). 4 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK871083 CM 5000 Monitor Airway PressureCanadian Monaghan, Ltd. · 1987
- This deviceK992101 Criterion 40 or PM 40Caradyne, Ltd. · 2000
- Descendant · cites it directly · 2 of its ownK221734 Maxtec MaxO2 ME+pMaxtec, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK251245 OxyMinder Pro (10310)Bio-Med Device, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK231895 Maxtec MaxBlend2+pMaxtec, LLC · 2023
- Descendant · cites it directly · 0 of its ownK182292 VORTRAN APM-PlusVortran Medical Technology 1, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK172284 NAPA LP-15 Airway Pressure MonitorDrw Medical, LLC · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K221734Maxtec MaxO2 ME+pMaxtec, LLC · 2023 · cites it directly2descendants
- K251245OxyMinder Pro (10310)Bio-Med Device, Inc. · 2025 · 2 generations on0descendants
- K231895Maxtec MaxBlend2+pMaxtec, LLC · 2023 · 2 generations on0descendants
- K182292VORTRAN APM-PlusVortran Medical Technology 1, Inc. · 2019 · cites it directly0descendants
- K172284NAPA LP-15 Airway Pressure MonitorDrw Medical, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871083 | CM 5000 Monitor Airway Pressure | Canadian Monaghan, Ltd. | 1987 | — |
| 0 (this device) | K992101 | Criterion 40 or PM 40 | Caradyne, Ltd. | 2000 | — |
| +1 | K221734 | Maxtec MaxO2 ME+p | Maxtec, LLC | 2023 | — |
| +2 | K251245 | OxyMinder Pro (10310) | Bio-Med Device, Inc. | 2025 | — |
| +2 | K231895 | Maxtec MaxBlend2+p | Maxtec, LLC | 2023 | — |
| +1 | K182292 | VORTRAN APM-Plus | Vortran Medical Technology 1, Inc. | 2019 | — |
| +1 | K172284 | NAPA LP-15 Airway Pressure Monitor | Drw Medical, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K871083 | CM 5000 Monitor Airway PressureSummary page 1…Classification Name: Airway Pressure Monitor (includes gauges and / or alarm) Device: Criterion 40 Predicate Devices: Monaghan, Ltd. CM 5000 Airway Pressure Monitor - K871083 R I TR . e Lo r i Toinindibraatodiaaadubhs waisdn SUSTAHIHRT I The Criterion 40 is a microprocessor controlled device that mea… | 1987 |
| * | K873953 | CM 5000R Remote Airway PressureSummary page 4…viewed as substantially equivalent to the following predicate device - Monaghan CM 5000 Airway Pressure Monitor (APM) cleared under K871083 and other modifications under K873953, K925673, and K931394. The differences between the Criterion 40 and the predicate device are minimal. There are no significant d… | 1987 |
| * | K925673 | Airway Pressure Monitor CM 5000 NganSummary page 4…substantially equivalent to the following predicate device - Monaghan CM 5000 Airway Pressure Monitor (APM) cleared under K871083 and other modifications under K873953, K925673, and K931394. The differences between the Criterion 40 and the predicate device are minimal. There are no significant difference… | 1993 |
| * | K931394 | CM5000R Remote IndicatorSummary page 4…y equivalent to the following predicate device - Monaghan CM 5000 Airway Pressure Monitor (APM) cleared under K871083 and other modifications under K873953, K925673, and K931394. The differences between the Criterion 40 and the predicate device are minimal. There are no significant differences that affect… | 1993 |
What descends from it? (6)
4 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?
- None of the 4 ancestors has a recall.
- Of its descendants, K221734 (Maxtec, LLC, 2023) has gone furthest, with 2 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 | — |
What is it indicated for?
Is intended to measure airway pressure when used with positive pressure devices. The device alarms when the airway pressure falls outside of the user selected high and low alarm limits and displays peak pressure and real-time airway pressures. It may be used with positive pressure devices which do not include pressure measurement capabilities, e.g. resuscitation bags or basic ventilators, or as an independent backup pressure monitor for devcies with pressure measurement capability. Environment of use is hospital, home, and sub-acute institutions. The device has been designed for stationary and intra-institution transport only.
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/K992101 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992101: Criterion 40 or PM 40.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992101
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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