510(k) · Cleared
ClearedPressure Manometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neoforce Group, Inc. · CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Cleared on Jun 10, 2011 as substantially equivalent to K954486 (Mercury Medical, 1996) and 4 other predicates after a 143-day review. Its family tree reaches back 6 generations to 1986. 1 later device descends from it.
- Decided
- Jun 10, 2011
- Review
- 143 days
- Class
- Class II
- Product code
- CAP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K862830 (1986). 19 ancestors in all, the oldest K801883 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK862830 Models 2R and 3R Pneupac Ventilator/ResuscitatorPneupac, Ltd. · 1986
- 5 generations backK024344 Pneuton VentilatorAiron Corporation · 2003
- 4 generations backK043085 Modification to: Pneuton VentilatorAiron Corporation · 2004
- 3 generations backK080692 Macs Cpap SystemAiron Corporation · 2008
- 2 generations backK092085 Ispira Resuscitation UnitNeoforce Group, Inc. · 2009
- 1 generation backK102649 Neopop Infant Resuscitator with Flow MeterNeoforce Group, Inc. · 2011
- This deviceK110119 Pressure ManometerNeoforce Group, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK122627 Gio Digital Pressure GuagesGalemed Corp. · 2013
Most influential descendants
Showing 1 of 1 · See all- K122627Gio Digital Pressure GuagesGalemed Corp. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K862830 | Models 2R and 3R Pneupac Ventilator/Resuscitator | Pneupac, Ltd. | 1986 | — |
| −5 | K024344 | Pneuton Ventilator | Airon Corporation | 2003 | — |
| −4 | K043085 | Modification to: Pneuton Ventilator | Airon Corporation | 2004 | — |
| −3 | K080692 | Macs Cpap System | Airon Corporation | 2008 | — |
| −2 | K092085 | Ispira Resuscitation Unit | Neoforce Group, Inc. | 2009 | — |
| −1 | K102649 | Neopop Infant Resuscitator with Flow Meter | Neoforce Group, Inc. | 2011 | — |
| 0 (this device) | K110119 | Pressure Manometer | Neoforce Group, Inc. | 2011 | — |
| +1 | K122627 | Gio Digital Pressure Guages | Galemed Corp. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (6)
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 |
|---|---|---|---|
| * | K954486 | Mercury Airway Pressure ManometerSummary page 1…re Monitor, CAP, Class 11 Performance Standards: None applicable Predicate Device: Pre-Amendment Pressure Manometer Anesthesia Associates Inc. K954486 Mercury Medical Disposable Color Coded Manometer K040991 Ambu Inc, Disposable Pressure Manometer K(072021 NeoPIP… | 1996 |
| * | K040991 | Ambu Disposable Pressure ManometerSummary page 1…plicable Predicate Device: Pre-Amendment Pressure Manometer Anesthesia Associates Inc. K954486 Mercury Medical Disposable Color Coded Manometer K040991 Ambu Inc, Disposable Pressure Manometer K(072021 NeoPIP Infant Resuscitation Device K092085 Ispira Resuscitation… | 2004 |
| * | K072021 | Neopip Infant ResuscitatorSummary page 1…e Manometer Anesthesia Associates Inc. K954486 Mercury Medical Disposable Color Coded Manometer K040991 Ambu Inc, Disposable Pressure Manometer K(072021 NeoPIP Infant Resuscitation Device K092085 Ispira Resuscitation System K1 02649 NeoPIP Infant Resuscitator with F… | 2007 |
| * | K092085 | Ispira Resuscitation UnitSummary page 1…4486 Mercury Medical Disposable Color Coded Manometer K040991 Ambu Inc, Disposable Pressure Manometer K(072021 NeoPIP Infant Resuscitation Device K092085 Ispira Resuscitation System K1 02649 NeoPIP Infant Resuscitator with Flow meter Device Description The NF-009 Pressure M… | 2009 |
| * | K102649 | Neopop Infant Resuscitator with Flow MeterSummary page 1…Manometer K040991 Ambu Inc, Disposable Pressure Manometer K(072021 NeoPIP Infant Resuscitation Device K092085 Ispira Resuscitation System K1 02649 NeoPIP Infant Resuscitator with Flow meter Device Description The NF-009 Pressure Manometer is a low pressure gauge with a range… | 2011 |
| * | — | Pre-Amendment Pressure Manometer Anesthesia Associates Inc. Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122627 | Gio Digital Pressure Guages | 2013 | 0 |
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 25 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K122627 (Galemed Corp., 2013) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K954486.
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. 2011, 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?
The Pressure Manometer is used to provide visual indication of patient's airway pressure during ventilation. It may be attached by flexible tubing to devices providing expiratory pressure such as resuscitation bags, hyperinflation bags, CPAP Masks or Circuits.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110119: 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/K110119
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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