510(k) · Cleared
ClearedEasy on-PC Spirometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ndd Medizitechnik AG · BZG Spirometer, Diagnostic
Cleared on Jun 2, 2009 as substantially equivalent to K002499 (Brentwood Medical Technology Corp., 2000) after a 147-day review. Its family tree reaches back 1 generation to 2000. 5 later devices descend from it.
- Decided
- Jun 2, 2009
- Review
- 147 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002499 (2000). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002499 Brentwood Iqmark Digital Spirometer (Includes Disposable Pneumotach…Brentwood Medical Technology Corp. · 2000
- This deviceK090034 Easy on-PC SpirometerNdd Medizitechnik AG · 2009
- Descendant · cites it directly · 4 of its ownK123896 CCS-200 SpirometerBenson Medical Instruments Co. · 2013
- Descendant · 2 generations on · 3 of its ownK130322 SPM-300Bionet Co., Ltd. · 2013
- Descendant · 3 generations on · 2 of its ownK220535 Cardio10Bionet Co., Ltd. · 2022
- Descendant · 4 generations on · 0 of its ownK231160 Cardio Q50, Cardio Q70Bionet Co., Ltd. · 2023
- Descendant · 4 generations on · 0 of its ownK231150 Cardio P1Bionet Co., Ltd. · 2023
Most influential descendants
Showing 5 of 5 · See all- K123896CCS-200 SpirometerBenson Medical Instruments Co. · 2013 · cites it directly4descendants
- K130322SPM-300Bionet Co., Ltd. · 2013 · 2 generations on3descendants
- K220535Cardio10Bionet Co., Ltd. · 2022 · 3 generations on2descendants
- K231160Cardio Q50, Cardio Q70Bionet Co., Ltd. · 2023 · 4 generations on0descendants
- K231150Cardio P1Bionet Co., Ltd. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002499 | Brentwood Iqmark Digital Spirometer (Includes Disposable Pneumotach… | Brentwood Medical Technology Corp. | 2000 | — |
| 0 (this device) | K090034 | Easy on-PC Spirometer | Ndd Medizitechnik AG | 2009 | — |
| +1 | K123896 | CCS-200 Spirometer | Benson Medical Instruments Co. | 2013 | — |
| +2 | K130322 | SPM-300 | Bionet Co., Ltd. | 2013 | — |
| +3 | K220535 | Cardio10 | Bionet Co., Ltd. | 2022 | — |
| +4 | K231160 | Cardio Q50, Cardio Q70 | Bionet Co., Ltd. | 2023 | — |
| +4 | K231150 | Cardio P1 | Bionet Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K002499 | Brentwood Iqmark Digital Spirometer (Includes Disposable Pneumotach Mouthpieces and…Summary page 1…BZG Predicate device: Substantial equivalence is claimed to the Brentwood/Midmark Diagnostics lQmark Digital Spirometer, cleared for commercial distribution per K002499. Device Description: Easy on-PC is a PC based diagnostic spirometer and consists of a PC software and the Easy on-PC sensor (Sp… | 2000 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123896 | CCS-200 Spirometer | 2013 | 4 |
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?
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 ndd Medical Technologies Easy on-PC Spirometer is intended for prescriptions use only to conduct diagnostic spirometry testing of adults and pediatric patients over 4 years old, in general practice and specialty physician, industrial and hospital settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090034 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090034: Easy on-PC Spirometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090034
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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