510(k) · Cleared
ClearedTD-7301 Spirometer (TD-7301)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gostar Co., Ltd. · BZG Spirometer, Diagnostic
Cleared on Nov 20, 2024 as substantially equivalent to K073155 (Vitalograph (Ireland), Ltd., 2008) after a 147-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Nov 20, 2024
- Review
- 147 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K901057 (1990). No later device cites it as a predicate yet.
- Root · 4 generations backK901057 Spirometrics Model 2600 Miro SpirometerSpirometrics, Inc. · 1990
- 3 generations backK963035 Micro SpirometerMicro Direct, Inc. · 1996
- 2 generations backK061283 PulmolifeMicro Medical, Ltd. · 2006
- 1 generation backK073155 Vitalograph Model 4000 (Asma-1 and Copd-6)Vitalograph (Ireland), Ltd. · 2008
- This deviceK241843 TD-7301 Spirometer (TD-7301)Gostar Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K901057 | Spirometrics Model 2600 Miro Spirometer | Spirometrics, Inc. | 1990 | — |
| −3 | K963035 | Micro Spirometer | Micro Direct, Inc. | 1996 | — |
| −2 | K061283 | Pulmolife | Micro Medical, Ltd. | 2006 | — |
| −1 | K073155 | Vitalograph Model 4000 (Asma-1 and Copd-6) | Vitalograph (Ireland), Ltd. | 2008 | — |
| 0 (this device) | K241843 | TD-7301 Spirometer (TD-7301) | Gostar Co., Ltd. | 2024 | — |
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 BZG? 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 BZG device
- #1 K251777 MESI mTABLET SPIROscore 13.0 · 8 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K073155 | Vitalograph Model 4000 (Asma-1 and Copd-6)Summary page 5…ssification 2 Regulation Number 21 CFR 868.1840 3) Predicate Device Information K number K073155 Proprietary Name VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6) Regulation Description Diag… | 2008 |
| † | K222810 | TD-7301 Peak Flow meter | 2023 |
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?
- The line of descent spans 34 years and passes through 5 companies; a new generation was cleared every 10.1 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K073155.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · BZG
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZG
362in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZG
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZG
1in 2025
MAUDE reports naming product code BZG, 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 | 3 | 121 | 0 | 1 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 8 | 141 | 0 | 0 |
| 2010 | 4 | 181 | 0 | 0 |
| 2011 | 6 | 278 | 0 | 1 |
| 2012 | 3 | 59 | 0 | 2 |
| 2013 | 3 | 266 | 0 | 1 |
| 2014 | 5 | 154 | 0 | 1 |
| 2015 | 5 | 273 | 0 | 1 |
| 2016 | 4 | 235 | 0 | 1 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 3 | 146 | 0 | 1 |
| 2020 | 5 | 126 | 0 | 2 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 3 |
| 2023 | 5 | 362 | 0 | 2 |
| 2024 | 2 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241843 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241843: TD-7301 Spirometer (TD-7301).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241843
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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