510(k) · Cleared
ClearedMicro Spirometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Direct, Inc. · BZG Spirometer, Diagnostic
Cleared on Nov 1, 1996 as substantially equivalent to K901057 (Spirometrics, Inc., 1990) after an 88-day review. Its family tree reaches back 1 generation to 1990. 7 later devices descend from it.
- Decided
- Nov 1, 1996
- Review
- 88 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K901057 (1990). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK901057 Spirometrics Model 2600 Miro SpirometerSpirometrics, Inc. · 1990
- This deviceK963035 Micro SpirometerMicro Direct, Inc. · 1996
- Descendant · cites it directly · 3 of its ownK061283 PulmolifeMicro Medical, Ltd. · 2006
- Descendant · 2 generations on · 2 of its ownK073155 Vitalograph Model 4000 (Asma-1 and Copd-6)Vitalograph (Ireland), Ltd. · 2008
- Descendant · cites it directly · 2 of its ownK965042 Microdl Diarycard SpirometerMicro Direct, Inc. · 1997
- Descendant · 2 generations on · 1 of its ownK100928 Micro Diary SpirometerViasys Respiratory Care, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK241843 TD-7301 Spirometer (TD-7301)Gostar Co., Ltd. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K061283PulmolifeMicro Medical, Ltd. · 2006 · cites it directly3descendants
- K073155Vitalograph Model 4000 (Asma-1 and Copd-6)Vitalograph (Ireland), Ltd. · 2008 · 2 generations on2descendants
- K965042Microdl Diarycard SpirometerMicro Direct, Inc. · 1997 · cites it directly2descendants
- K100928Micro Diary SpirometerViasys Respiratory Care, Inc. · 2011 · 2 generations on1descendant
- K241843TD-7301 Spirometer (TD-7301)Gostar Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K901057 | Spirometrics Model 2600 Miro Spirometer | Spirometrics, Inc. | 1990 | — |
| 0 (this device) | K963035 | Micro Spirometer | Micro Direct, Inc. | 1996 | — |
| +1 | K061283 | Pulmolife | Micro Medical, Ltd. | 2006 | — |
| +2 | K073155 | Vitalograph Model 4000 (Asma-1 and Copd-6) | Vitalograph (Ireland), Ltd. | 2008 | — |
| +1 | K965042 | Microdl Diarycard Spirometer | Micro Direct, Inc. | 1997 | — |
| +2 | K100928 | Micro Diary Spirometer | Viasys Respiratory Care, Inc. | 2011 | — |
| +3 | K241843 | TD-7301 Spirometer (TD-7301) | Gostar Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2024 | 1 | 0 |
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 |
|---|---|---|---|
| * | K901057 | Spirometrics Model 2600 Miro SpirometerSummary page 1…0 David R. Staszak, President Micro Spirometer Diagnostic Spirometer 73 BZG - Diagnostic Spirometer Diagnostic spirometer Spirometrics Model 2600 Micro Spirometer - K901057 A hand-held portable electronic spirometer measuring FEV1 and FVC. The intended device takes spirometer readings of a patient d… | 1990 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- Of its descendants, K061283 (Micro Medical, Ltd., 2006) has gone furthest, with 3 descendants of its own.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The intended device takes spirometer readings of a patient during exhalation. The output readings are FEV1 and FVC.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963035 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963035: Micro Spirometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963035
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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