510(k) · Cleared
ClearedPulmolife
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Medical, Ltd. · BZG Spirometer, Diagnostic
Cleared on Dec 14, 2006 as substantially equivalent to K963035 (Micro Direct, Inc., 1996) after a 220-day review. Its family tree reaches back 2 generations to 1990. 3 later devices descend from it.
- Decided
- Dec 14, 2006
- Review
- 220 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K901057 (1990). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK901057 Spirometrics Model 2600 Miro SpirometerSpirometrics, Inc. · 1990
- 1 generation backK963035 Micro SpirometerMicro Direct, Inc. · 1996
- This deviceK061283 PulmolifeMicro Medical, Ltd. · 2006
- Descendant · cites it directly · 2 of its ownK073155 Vitalograph Model 4000 (Asma-1 and Copd-6)Vitalograph (Ireland), Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK241843 TD-7301 Spirometer (TD-7301)Gostar Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK103575 Spiro PDPmd Healthcare · 2011
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901057 | Spirometrics Model 2600 Miro Spirometer | Spirometrics, Inc. | 1990 | — |
| −1 | K963035 | Micro Spirometer | Micro Direct, Inc. | 1996 | — |
| 0 (this device) | K061283 | Pulmolife | Micro Medical, Ltd. | 2006 | — |
| +1 | K073155 | Vitalograph Model 4000 (Asma-1 and Copd-6) | Vitalograph (Ireland), Ltd. | 2008 | — |
| +2 | K241843 | TD-7301 Spirometer (TD-7301) | Gostar Co., Ltd. | 2024 | — |
| +2 | K103575 | Spiro PD | Pmd Healthcare | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K963035 | Micro SpirometerSummary page 1…ted predicate devices to which substantial equivalence is claimed: Micro Medical Ltd. Micro Spirometer, Model No. MS01/3. Ref. 510(k) No. K963035, approved by FDA on November 1, 1996. pulmolife-510ksecB Section B… | 1996 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073155 | Vitalograph Model 4000 (Asma-1 and Copd-6) | 2008 | 2 |
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 16 years and passes through 3 companies; a new generation was cleared every 10.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K073155 (Vitalograph (Ireland), Ltd., 2008) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K963035.
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 device measures expiratory lung function parameters, specifically FEVI and conforms to ATS standards for diagnostic devices. The results obtained can be used for screening of COPD in adult smokers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061283 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061283: Pulmolife.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061283
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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