510(k) · Cleared
ClearedMedikro Nano, Medikro Primo and Medikro Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medikro OY · BZG Spirometer, Diagnostic
Cleared on May 21, 2014 as substantially equivalent to K971336 (Caird Technology, 1998) and 1 other predicate after a 194-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- May 21, 2014
- Review
- 194 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K935732 (1996). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935732 | Cardio Perfect ST 2001 | Cardio Control BV | 1996 | — |
| −1 | K052158 | Welch Allyn Cardioperfect Workstation Version 1.5.0 Software | Welch Allyn, Inc. | 2005 | — |
| 0 (this device) | K133428 | Medikro Nano, Medikro Primo and Medikro Pro | Medikro OY | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 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 |
|---|---|---|---|
| * | K971336 | Caird Technology SpirometerSummary page 1…or tel: +358 17 283 3000 fax: ±358 17 283 3300 Predicate Devices: Caird Technology Spirometer, K971336 Welch Allyn CardioPerfect Workstation, Software Version 1.5.0, K05… | 1998 |
| * | K052158 | Welch Allyn Cardioperfect Workstation Version 1.5.0 SoftwareSummary page 1…Caird Technology Spirometer, K971336 Welch Allyn CardioPerfect Workstation, Software Version 1.5.0, K052158 Device Description Medikro® spirometer runs on a persona! computer with Microsoft Windows operating systems. Medikro®&spiromet… | 2005 |
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 18 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- None of the 4 ancestors has a recall.
- 4 other devices also cite its predicate K971336.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Medikro®D Spironieter is a device that measures lung air volume and airflow rate for
pulmonary disease diagnosis and screening. These measurements provide information about a
patient's pulmonary function which may be compared with normal values or the patient's
previous values.
The device is designed to test pulmonary function and obtain spirometric indices for
" adult and pediatric patients 12 years and older,
* hospital and clinic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133428 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133428: Medikro Nano, Medikro Primo and Medikro Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133428
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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