510(k) · Cleared
ClearedDisposable Pressure Manometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Besmed Health Business Corp · CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Cleared on Jun 19, 2014 as substantially equivalent to K003497 (Engineered Medical Systems, 2000) after a 125-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Jun 19, 2014
- Review
- 125 days
- Class
- Class II
- Product code
- CAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003497 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK003497 Disposable Pressure MonitorEngineered Medical Systems · 2000
- This deviceK140370 Disposable Pressure ManometerBesmed Health Business Corp · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003497 | Disposable Pressure Monitor | Engineered Medical Systems | 2000 | — |
| 0 (this device) | K140370 | Disposable Pressure Manometer | Besmed Health Business Corp | 2014 | — |
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? (1)
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 |
|---|---|---|---|
| * | K003497 | Disposable Pressure MonitorSummary page 1…2I1CFR 868,2600 CAP - Airway Pressure Monitor Class 11 Predicate Devices: K003497 -Engineered Medical Systems - Pressure Monitor Device Description: The Besmed disposable pressure manometer is a means of provid… | 2000 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K003497.
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. 2014, this device’s year, is highlighted.
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?
To provide visual indication of a patient's airway pressure during ventilation, It may be attached to the manometer port or proximal port on ventilation devices such as resuscitation bags, hyperinflation bags, CPAP mask, or CPAP circuits. For patients that the clinician desires to monitor or measure airway or circuit pressure, including neonates to adults. Home, Physician office, Hospital. Sub-acute Institutions, Emergency services or anywhere measurement of airway pressure is desired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140370: Disposable Pressure Manometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140370
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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