# K241152: InSee

- Pathway: 510(k) (Traditional)
- Applicant: Tidal Medical Technologies, LLC
- Decided: Aug 21, 2025 after 482 days
- Product code: BWF (Spirometer, Therapeutic (Incentive))
- Device class: 2
- Regulation: 21 CFR 868.5690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K781838 (1978). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K781838: Calculator, with Charger, C.R. Bard, Inc. (1978) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K241152
Methodology: https://510kreport.com/methodology