510(k) · Cleared
ClearedVentiplus Disposable Manometer 0-60 CM H2O; Ventiplus Disposable Manometer 0-20 CM H2O; Ventiplus Disposable Manometer 0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A Plus Medical · CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Cleared on Nov 18, 2010 as substantially equivalent to K961318 (Intertech Resources, Inc., 1996) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Nov 18, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- CAP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K961318 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK961318 1ST Response Disposable ManometerIntertech Resources, Inc. · 1996
- 1 generation backK092687 Venti.Plus Hyperinflation Bag System with Pressure ManometerA Plus Medical · 2009
- This deviceK102377 Ventiplus Disposable Manometer 0-60 CM H2O; Ventiplus Disposable…A Plus Medical · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961318 | 1ST Response Disposable Manometer | Intertech Resources, Inc. | 1996 | — |
| −1 | K092687 | Venti.Plus Hyperinflation Bag System with Pressure Manometer | A Plus Medical | 2009 | — |
| 0 (this device) | K102377 | Ventiplus Disposable Manometer 0-60 CM H2O; Ventiplus Disposable Manometer… | A Plus Medical | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (2)
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 |
|---|---|---|---|
| * | K961318 | 1ST Response Disposable ManometerSummary page 1…Pressure Product Code: CAP Regulation: CFR 868.2600 Device Class: II Device: V1At9.0Plus Disposable Pressure Manometer Predicate Devices: Number: K961318 Product Name: lI" Response Disposable Manometer Manufacturer: Smithis Medical (Intertech Resources) Product Codes: 008… | 1996 |
| * | K092687 | Venti.Plus Hyperinflation Bag System with Pressure ManometerSummary page 1…K961318 Product Name: lI" Response Disposable Manometer Manufacturer: Smithis Medical (Intertech Resources) Product Codes: 008201 Number: K092687 Product Name: VIattPiur Hyperinflation Bag System with Pressure Manometer Manufacturer: A Plus Medical… | 2009 |
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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 12.9 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K961318.
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. 2010, 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?
Intended for use where monitoring airway pressure is desired. This device provides a visual indication of airway pressure and may be used on all patient populations in the hospital, pre-hospital, post-hospital and home care environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102377: Ventiplus Disposable Manometer 0-60 CM H2O; Ventiplus Disposable Manometer 0-20 CM H2O; Ventiplus Disposable Manometer 0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102377
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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