510(k) · Cleared
ClearedMESI mTABLET SPIRO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mesi D.O.O. · BZG Spirometer, Diagnostic
Cleared on Mar 2, 2026 as substantially equivalent to K212938 (Vitalograph Ireland, Ltd., 2022) after a 265-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Mar 2, 2026
- Review
- 265 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K896120 (1990). 19 ancestors in all, the oldest K831779 (1983). No later device cites it as a predicate yet.
- Root · 8 generations backK896120 Schiller Model SP-100 Spirovit (TM)Schiller America, Inc. · 1990
- 7 generations backK984031 Spirovit, Model SP-250Schiller AG · 1999
- 6 generations backK992823 Spirovit SP-2, Pneumocheck IISchiller AG · 2000
- 5 generations backK022276 KokomateFerraris Respiratory, Inc. · 2002
- 4 generations backK051572 Koko LegendPulmonary Data Services, Inc. · 2005
- 3 generations backK100687 Vitalograph Hand Held Spirometer, Model 2120Vitalograph (Ireland), Ltd. · 2010
- 2 generations backK200550 Vitalograph Model 2120 In2itive eDiaryVitalograph Ireland, Ltd. · 2020
- 1 generation backK212938 Vitalograph Model 6000 AlphaVitalograph Ireland, Ltd. · 2022
- This deviceK251777 MESI mTABLET SPIROMesi D.O.O. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K896120 | Schiller Model SP-100 Spirovit (TM) | Schiller America, Inc. | 1990 | — |
| −7 | K984031 | Spirovit, Model SP-250 | Schiller AG | 1999 | — |
| −6 | K992823 | Spirovit SP-2, Pneumocheck II | Schiller AG | 2000 | — |
| −5 | K022276 | Kokomate | Ferraris Respiratory, Inc. | 2002 | — |
| −4 | K051572 | Koko Legend | Pulmonary Data Services, Inc. | 2005 | — |
| −3 | K100687 | Vitalograph Hand Held Spirometer, Model 2120 | Vitalograph (Ireland), Ltd. | 2010 | — |
| −2 | K200550 | Vitalograph Model 2120 In2itive eDiary | Vitalograph Ireland, Ltd. | 2020 | — |
| −1 | K212938 | Vitalograph Model 6000 Alpha | Vitalograph Ireland, Ltd. | 2022 | — |
| 0 (this device) | K251777 | MESI mTABLET SPIRO | Mesi D.O.O. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2009 | 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 K241843 TD-7301 Spirometer (TD-7301)score 9.3 · 4 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 |
|---|---|---|---|
| * | K212938 | Vitalograph Model 6000 AlphaSummary page 5…Class II Product classification 868.1840 Product code BZG Classification panel Anesthesiology; Spirometer, diagnostic Predicate Device: K212938: Vitalograph Model 6000 Alpha Common Name: Diagnostic Spirometer Classification #: 868.1840 Regulatory Class… | 2022 |
| † | K201046 | Automated ankle brachial pressure index measuring device, MESI mTABLET system | 2020 |
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 36 years and passes through 7 companies; a new generation was cleared every 4.1 years on median.
- None of the 19 ancestors has a recall.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 MESI mTABLET SPIRO is indicated for use to conduct assessment of respiratory function by way of measurement of dynamic lung volumes (also known as spirometry) on adult and pediatric patients, ages 5 years and older. The device measures patient respiratory parameters including FVC, FEV1, FEV6, and VC. MESI mTABLET SPIRO is intended to be operated by medical professionals in health care environments including primary care facilities, hospitals and health centers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251777 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251777: MESI mTABLET SPIRO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251777
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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