510(k) · Cleared
ClearedDisposable Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Engineered Medical Systems · CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Cleared on Nov 30, 2000 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Nov 30, 2000
- Review
- 17 days
- Class
- Class II
- Product code
- CAP
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK003497 Disposable Pressure MonitorEngineered Medical Systems · 2000
- Descendant · cites it directly · 0 of its ownK153733 VORTRAN ManometerVortran Medical Technology 1, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK143148 Disposable Pressure Manometer (DPM)Westmed, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK140370 Disposable Pressure ManometerBesmed Health Business Corp · 2014
- Descendant · cites it directly · 0 of its ownK022402 Disposable Pressure ManometerVital Signs, Inc. · 2002
Most influential descendants
Showing 4 of 4 · See all- K153733VORTRAN ManometerVortran Medical Technology 1, Inc. · 2016 · cites it directly0descendants
- K143148Disposable Pressure Manometer (DPM)Westmed, Inc. · 2015 · cites it directly0descendants
- K140370Disposable Pressure ManometerBesmed Health Business Corp · 2014 · cites it directly0descendants
- K022402Disposable Pressure ManometerVital Signs, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003497 | Disposable Pressure Monitor | Engineered Medical Systems | 2000 | — |
| +1 | K153733 | VORTRAN Manometer | Vortran Medical Technology 1, Inc. | 2016 | — |
| +1 | K143148 | Disposable Pressure Manometer (DPM) | Westmed, Inc. | 2015 | — |
| +1 | K140370 | Disposable Pressure Manometer | Besmed Health Business Corp | 2014 | — |
| +1 | K022402 | Disposable Pressure Manometer | Vital Signs, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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? (4)
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?
- Of its descendants, K153733 (Vortran Medical Technology 1, Inc., 2016) has gone furthest, with 0 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/K003497 · printed Nov 4, 2026
Cite this page
510(k) Report. “K003497: Disposable Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003497
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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