510(k) · Cleared
ClearedVitalograph Model 2120 In2itive eDiary
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 Jul 27, 2020 as substantially equivalent to K100687 (Vitalograph (Ireland), Ltd., 2010) after a 146-day review. Its family tree reaches back 6 generations to 1990. 2 later devices descend from it.
- Decided
- Jul 27, 2020
- Review
- 146 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K896120 (1990). 17 ancestors in all, the oldest K831779 (1983). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK896120 Schiller Model SP-100 Spirovit (TM)Schiller America, Inc. · 1990
- 5 generations backK984031 Spirovit, Model SP-250Schiller AG · 1999
- 4 generations backK992823 Spirovit SP-2, Pneumocheck IISchiller AG · 2000
- 3 generations backK022276 KokomateFerraris Respiratory, Inc. · 2002
- 2 generations backK051572 Koko LegendPulmonary Data Services, Inc. · 2005
- 1 generation backK100687 Vitalograph Hand Held Spirometer, Model 2120Vitalograph (Ireland), Ltd. · 2010
- This deviceK200550 Vitalograph Model 2120 In2itive eDiaryVitalograph Ireland, Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK212938 Vitalograph Model 6000 AlphaVitalograph Ireland, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK251777 MESI mTABLET SPIROMesi D.O.O. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K896120 | Schiller Model SP-100 Spirovit (TM) | Schiller America, Inc. | 1990 | — |
| −5 | K984031 | Spirovit, Model SP-250 | Schiller AG | 1999 | — |
| −4 | K992823 | Spirovit SP-2, Pneumocheck II | Schiller AG | 2000 | — |
| −3 | K022276 | Kokomate | Ferraris Respiratory, Inc. | 2002 | — |
| −2 | K051572 | Koko Legend | Pulmonary Data Services, Inc. | 2005 | — |
| −1 | K100687 | Vitalograph Hand Held Spirometer, Model 2120 | Vitalograph (Ireland), Ltd. | 2010 | — |
| 0 (this device) | K200550 | Vitalograph Model 2120 In2itive eDiary | Vitalograph Ireland, Ltd. | 2020 | — |
| +1 | K212938 | Vitalograph Model 6000 Alpha | Vitalograph Ireland, Ltd. | 2022 | — |
| +2 | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K100687 | Vitalograph Hand Held Spirometer, Model 2120Summary page 4…: Diagnostic spirometer (21 CFR 868.1840) Regulatory Class: II Product Code: BZG III. Predicate Device: K100687 – Vitalograph Model 2120 IV. Device Description: The Vitalograph Model 2120 In2itive eDiary is a hand-held, battery-operate… | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212938 | Vitalograph Model 6000 Alpha | 2022 | 1 |
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 30 years and passes through 6 companies; a new generation was cleared every 4.9 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K212938 (Vitalograph Ireland, Ltd., 2022) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K100687.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Vitalograph Model 2120 In2itive eDiary device is a battery-operated spirometer which measures three basic patient respiratory parameters (FVC, MVV and VC). The Vitalograph Model 2120 In2itive eDiary is a handheld spirometer designed for lung function testing in a variety of environments such as hospital wards, health centres and private homes. It is intended for Adults and pediatrics, 5 years and older.
The Vitalograph Model 2120 In2itive eDiary can be configured as a stand-alone spirometer or connected to a printer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200550 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200550: Vitalograph Model 2120 In2itive eDiary.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200550
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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