510(k) · Cleared
ClearedInSee
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tidal Medical Technologies, LLC · BWF Spirometer, Therapeutic (Incentive)
Cleared on Aug 21, 2025 as substantially equivalent to K781838 (C.R. Bard, Inc., 1978) after a 482-day review. Its family tree reaches back 1 generation to 1978.
- Decided
- Aug 21, 2025
- Review
- 482 days
- Class
- Class II
- Product code
- BWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K781838 (1978). No later device cites it as a predicate yet.
- Root · 1 generation backK781838 Calculator, with ChargerC.R. Bard, Inc. · 1978
- This deviceK241152 InSeeTidal Medical Technologies, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K781838 | Calculator, with Charger | C.R. Bard, Inc. | 1978 | — |
| 0 (this device) | K241152 | InSee | Tidal Medical Technologies, LLC | 2025 | — |
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 BWF? 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 BWF device
- #1 K233855 AllPEPscore 7.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
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 BWF devicesBWF Spirometer, Therapeutic (Incentive): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · BWF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BWF
281in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BWF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BWF
3in 2025
MAUDE reports naming product code BWF, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 39 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 19 |
| 2014 | 3 | 105 | 0 | 5 |
| 2015 | 1 | — | 0 | 16 |
| 2016 | 3 | 149 | 0 | 6 |
| 2017 | 3 | 136 | 0 | 7 |
| 2018 | 1 | — | 0 | 7 |
| 2019 | 3 | 281 | 0 | 16 |
| 2020 | 1 | — | 1 | 5 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 1 | — | 0 | 8 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 11 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
InSee is an accessory to the Vyaire Medical AirLife Incentive Spirometer (2500 mL and 4000 mL). InSee is indicated to
flag and digitally record successful incentive spirometry attempts, use-related data and provide reminders to patients who
are prescribed the Vyaire Medical AirLife Incentive Spirometer. It is intended to be used in a hospital environment by
clinicians and patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241152: InSee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241152
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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