510(k) · Cleared
ClearedNS Series Vacuum/Pressure Gauges, Cuff Pressure Monitors
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 Sep 12, 2008 after an 81-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Sep 12, 2008
- Review
- 81 days
- Class
- Class II
- Product code
- CAP
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK081778 NS Series Vacuum/Pressure Gauges, Cuff Pressure MonitorsInstrumentation Industries, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK180510 NS 120P-TRS Airway Pressure GaugeInstrumentation Industries, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K180510NS 120P-TRS Airway Pressure GaugeInstrumentation Industries, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081778 | NS Series Vacuum/Pressure Gauges, Cuff Pressure Monitors | Instrumentation Industries, Inc. | 2008 | — |
| +1 | K180510 | NS 120P-TRS Airway Pressure Gauge | Instrumentation Industries, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | — | Instrumentation Industries, Inc. - BE 148 Named without a submission number | |
| * | — | Anesthesia Associates, Inc. Model # 00-199 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 |
|---|---|---|---|
| K180510 | NS 120P-TRS Airway Pressure Gauge | 2019 | 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?
- Of its descendants, K180510 (Instrumentation Industries, Inc., 2019) 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. 2008, 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 Series Airway Pressure Monitors are devices
used to monitor patient airway pressure during ventilation within a breathing circuit. The
pressure gauge is placed in the patient circuit at a point that provides optimal airway
pressure readings.
These devices are intended to be used by or on the order of a physician.
During ventilation, the NS Series Cuff Pressure Monitors are devices used to
periodically monitor endotracheal or tracheostomy tube balloon pressure to assure an
adequate seal between the tube and the tracheal wall.
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/K081778 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081778: NS Series Vacuum/Pressure Gauges, Cuff Pressure Monitors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081778
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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