510(k) · Cleared
ClearedVitalograph Model 6000 Alpha
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitalograph Ireland, Ltd. · BZG Spirometer, Diagnostic
Cleared on Jan 26, 2022 as substantially equivalent to K200550 (Vitalograph Ireland, Ltd., 2020) after a 133-day review. Its family tree reaches back 7 generations to 1990. 1 later device descends from it.
- Decided
- Jan 26, 2022
- Review
- 133 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K896120 (1990). 18 ancestors in all, the oldest K831779 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK896120 Schiller Model SP-100 Spirovit (TM)Schiller America, Inc. · 1990
- 6 generations backK984031 Spirovit, Model SP-250Schiller AG · 1999
- 5 generations backK992823 Spirovit SP-2, Pneumocheck IISchiller AG · 2000
- 4 generations backK022276 KokomateFerraris Respiratory, Inc. · 2002
- 3 generations backK051572 Koko LegendPulmonary Data Services, Inc. · 2005
- 2 generations backK100687 Vitalograph Hand Held Spirometer, Model 2120Vitalograph (Ireland), Ltd. · 2010
- 1 generation backK200550 Vitalograph Model 2120 In2itive eDiaryVitalograph Ireland, Ltd. · 2020
- This deviceK212938 Vitalograph Model 6000 AlphaVitalograph Ireland, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK251777 MESI mTABLET SPIROMesi D.O.O. · 2026
Most influential descendants
Showing 1 of 1 · See all- K251777MESI mTABLET SPIROMesi D.O.O. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K896120 | Schiller Model SP-100 Spirovit (TM) | Schiller America, Inc. | 1990 | — |
| −6 | K984031 | Spirovit, Model SP-250 | Schiller AG | 1999 | — |
| −5 | K992823 | Spirovit SP-2, Pneumocheck II | Schiller AG | 2000 | — |
| −4 | K022276 | Kokomate | Ferraris Respiratory, Inc. | 2002 | — |
| −3 | K051572 | Koko Legend | Pulmonary Data Services, Inc. | 2005 | — |
| −2 | K100687 | Vitalograph Hand Held Spirometer, Model 2120 | Vitalograph (Ireland), Ltd. | 2010 | — |
| −1 | K200550 | Vitalograph Model 2120 In2itive eDiary | Vitalograph Ireland, Ltd. | 2020 | — |
| 0 (this device) | K212938 | Vitalograph Model 6000 Alpha | Vitalograph Ireland, Ltd. | 2022 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K200550 | Vitalograph Model 2120 In2itive eDiarySummary page 4…fication Name: Diagnostic spirometer (21 CFR 868.1840) Regulatory Class: II Product Code: BZG III. Predicate Device: K200550 – Vitalograph Model 2120 In2itive eDiary Proprietary or Trade Name: Vitalograph Model 2120 In2itive eDiary Common/Usual Nam… | 2020 |
| † | K201562 | Spirotrac | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251777 | MESI mTABLET SPIRO | 2026 | 0 |
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 32 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K251777 (Mesi D.O.O., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 intended use of the Vitalograph Model 6000 Alpha is the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. spirometry. The device measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The device is designed to be operated by medical professionals trained in respiratory and lung function testing on adults and pediatrics, 5 years and older, in a variety of professional healthcare environments, e.g. primary care, hospitals and occupational health centers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212938 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212938: Vitalograph Model 6000 Alpha.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212938
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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