510(k) · Cleared
ClearedNS Series Nif (Negative Inspiratory Force) Meters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Industries, Inc. · BXR Meter, Airway Pressure (Inspiratory Force)
Cleared on Sep 11, 2008 after an 86-day review. The FDA summary names its predicate without a number.
- Decided
- Sep 11, 2008
- Review
- 86 days
- Class
- Class II
- Product code
- BXR
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 BXR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | — | BE 149 Named without a submission number | |
| * | — | Smiths Medical NIF Kit Named without a submission number |
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.
How does its category compare?
All BXR devicesBXR Meter, Airway Pressure (Inspiratory Force): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · BXR
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · BXR
Too few BXR 510(k)s in any year since 2007 to give a median.
Recalls per year · BXR
No recall names BXR since 2007.
Adverse event reports per year · BXR
1in 2023
MAUDE reports naming product code BXR, 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 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Instrumentation Industries, Inc. Negative Inspiratory Force (NIF) Meters are devices used to measure and monitor patient inspiratory effort. During use the NIF Meter is attached to the patient airway at a point that provides optimal readings of patient respiratory effort.
Federal law restricts these devices to sale by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081693 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081693: NS Series Nif (Negative Inspiratory Force) Meters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081693
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026