510(k) · Cleared
ClearedSpirometrics Model 2600 Miro Spirometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spirometrics, Inc. · BZG Spirometer, Diagnostic
Cleared on Apr 3, 1990 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Apr 3, 1990
- Review
- 28 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK901057 Spirometrics Model 2600 Miro SpirometerSpirometrics, Inc. · 1990
- Descendant · cites it directly · 7 of its ownK963035 Micro SpirometerMicro Direct, Inc. · 1996
- Descendant · 2 generations on · 3 of its ownK061283 PulmolifeMicro Medical, Ltd. · 2006
- Descendant · 3 generations on · 2 of its ownK073155 Vitalograph Model 4000 (Asma-1 and Copd-6)Vitalograph (Ireland), Ltd. · 2008
- Descendant · 2 generations on · 2 of its ownK965042 Microdl Diarycard SpirometerMicro Direct, Inc. · 1997
- Descendant · 3 generations on · 1 of its ownK100928 Micro Diary SpirometerViasys Respiratory Care, Inc. · 2011
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K963035Micro SpirometerMicro Direct, Inc. · 1996 · cites it directly7descendants
- K061283PulmolifeMicro Medical, Ltd. · 2006 · 2 generations on3descendants
- K073155Vitalograph Model 4000 (Asma-1 and Copd-6)Vitalograph (Ireland), Ltd. · 2008 · 3 generations on2descendants
- K965042Microdl Diarycard SpirometerMicro Direct, Inc. · 1997 · 2 generations on2descendants
- K100928Micro Diary SpirometerViasys Respiratory Care, Inc. · 2011 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K901057 | Spirometrics Model 2600 Miro Spirometer | Spirometrics, Inc. | 1990 | — |
| +1 | K963035 | Micro Spirometer | Micro Direct, Inc. | 1996 | — |
| +2 | K061283 | Pulmolife | Micro Medical, Ltd. | 2006 | — |
| +3 | K073155 | Vitalograph Model 4000 (Asma-1 and Copd-6) | Vitalograph (Ireland), Ltd. | 2008 | — |
| +2 | K965042 | Microdl Diarycard Spirometer | Micro Direct, Inc. | 1997 | — |
| +3 | K100928 | Micro Diary Spirometer | Viasys Respiratory Care, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K963035 | Micro Spirometer | 1996 | 7 |
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?
- Of its descendants, K963035 (Micro Direct, Inc., 1996) has gone furthest, with 7 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 | — |
https://510kreport.com/device/K901057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K901057: Spirometrics Model 2600 Miro Spirometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K901057
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026