510(k) · Cleared
ClearedNS 120P-TRS Airway Pressure Gauge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Industries, Inc. · CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Cleared on May 1, 2019 as substantially equivalent to K081778 (Instrumentation Industries, Inc., 2008) after a 428-day review. Its family tree reaches back 1 generation to 2008.
- Decided
- May 1, 2019
- Review
- 428 days
- Class
- Class II
- Product code
- CAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K081778 (2008). No later device cites it as a predicate yet.
- Root · 1 generation backK081778 NS Series Vacuum/Pressure Gauges, Cuff Pressure MonitorsInstrumentation Industries, Inc. · 2008
- This deviceK180510 NS 120P-TRS Airway Pressure GaugeInstrumentation Industries, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K081778 | NS Series Vacuum/Pressure Gauges, Cuff Pressure Monitors | Instrumentation Industries, Inc. | 2008 | — |
| 0 (this device) | K180510 | NS 120P-TRS Airway Pressure Gauge | Instrumentation Industries, Inc. | 2019 | — |
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 |
|---|---|---|---|
| * | K081778 | NS Series Vacuum/Pressure Gauges, Cuff Pressure MonitorsSummary page 4…Pressure Classification Class II Regulation 21 CFR 868.2600 Product Code CAP Predicate Device NS 120-TRS Vacuum/Pressure Gauge K081778 Distributed by Instrumentation Industries, Inc. Device The Instrumentation Industries, Inc. NS 12… | 2008 |
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.
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. 2019, 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 Instrumentation Industries, Inc. NS 120P-TRS Airway Pressure Monitor is a device used to monitor patient airway pressure during ventilation with a manual resuscitation device or bag/mask unit.
These devices are intended to be used by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180510 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180510: NS 120P-TRS Airway Pressure Gauge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180510
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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