# K241843: TD-7301 Spirometer (TD-7301)

- Pathway: 510(k) (Traditional)
- Applicant: Gostar Co., Ltd.
- Decided: Nov 20, 2024 after 147 days
- Product code: BZG (Spirometer, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 868.1840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K901057 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073155: Vitalograph Model 4000 (Asma-1 and Copd-6), Vitalograph (Ireland), Ltd. (2008) Summary page 5.

## Indications for use
TD-7301 Spirometer is intended to monitor Peak Expiratory Flow (PEF), Forced Expiratory Volume (FEV) in home and professional healthcare environments. The device is designed for use with children over 5 years old, adolescent and adult subjects.

Source page: https://510kreport.com/device/K241843
Methodology: https://510kreport.com/methodology