510(k) · Cleared
ClearedSpiro PD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pmd Healthcare · BZG Spirometer, Diagnostic
Cleared on Nov 9, 2011 as substantially equivalent to K031643 (Sdi Diagnostics, Inc., 2003) and 1 other predicate after a 338-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Nov 9, 2011
- Review
- 338 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K901057 (1990). 5 ancestors in all. 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 deviceK103575 Spiro PDPmd Healthcare · 2011
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) | K103575 | Spiro PD | Pmd Healthcare | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (2)
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 |
|---|---|---|---|
| * | K031643 | Spirotel, Model 29-1020Summary page 1…gy Predicate Device Company Name Product Name 510(k) Number SDI Diagnostics Spirotel K031643 Vitalograph Model 4000 Series K073155 Device Description The SPIRO PD spirometer is an i… | 2003 |
| * | K073155 | Vitalograph Model 4000 (Asma-1 and Copd-6)Summary page 1…510(k) Number SDI Diagnostics Spirotel K031643 Vitalograph Model 4000 Series K073155 Device Description The SPIRO PD spirometer is an instrument that acquires mechanical signals and processes the information prov… | 2008 |
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 21 years and passes through 5 companies; a new generation was cleared every 6.6 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K031643.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The SPIRO PD spirometer is intended to be used by a patient under the instruction of a physician or respiratory therapist to test lung function in child, adolescent and adult. It is also intended to be used as a single-patient device only and can be used in the home, factory, hospital or physician's office.
The SPIRO PD spirometer is indicated for the following age groups:
* 2-12 years - Child
* 13-21 years - Adolescent
* 22 and over- Adult
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103575 · printed Nov 4, 2026
Cite this page
510(k) Report. “K103575: Spiro PD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103575
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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