510(k) · Cleared
ClearedVitalograph Hand Held Spirometer, Model 2120
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 Oct 16, 2010 as substantially equivalent to K946075 (Vitalograph, Inc., 1995) and 2 other predicates after a 220-day review. Its family tree reaches back 5 generations to 1990. 6 later devices descend from it.
- Decided
- Oct 16, 2010
- Review
- 220 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K896120 (1990). 16 ancestors in all, the oldest K831779 (1983). 6 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK896120 Schiller Model SP-100 Spirovit (TM)Schiller America, Inc. · 1990
- 4 generations backK984031 Spirovit, Model SP-250Schiller AG · 1999
- 3 generations backK992823 Spirovit SP-2, Pneumocheck IISchiller AG · 2000
- 2 generations backK022276 KokomateFerraris Respiratory, Inc. · 2002
- 1 generation backK051572 Koko LegendPulmonary Data Services, Inc. · 2005
- This deviceK100687 Vitalograph Hand Held Spirometer, Model 2120Vitalograph (Ireland), Ltd. · 2010
- Descendant · cites it directly · 2 of its ownK200550 Vitalograph Model 2120 In2itive eDiaryVitalograph Ireland, Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK212938 Vitalograph Model 6000 AlphaVitalograph Ireland, Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK142812 Vitalograph Model 6800 PneumotracVitalograph (Ireland), Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK251777 MESI mTABLET SPIROMesi D.O.O. · 2026
- Descendant · cites it directly · 0 of its ownK160253 Vitalograph Model 6300 microVitalograph (Ireland), Ltd. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K200550Vitalograph Model 2120 In2itive eDiaryVitalograph Ireland, Ltd. · 2020 · cites it directly2descendants
- K212938Vitalograph Model 6000 AlphaVitalograph Ireland, Ltd. · 2022 · 2 generations on1descendant
- K142812Vitalograph Model 6800 PneumotracVitalograph (Ireland), Ltd. · 2015 · cites it directly1descendant
- K251777MESI mTABLET SPIROMesi D.O.O. · 2026 · 3 generations on0descendants
- K160253Vitalograph Model 6300 microVitalograph (Ireland), Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K896120 | Schiller Model SP-100 Spirovit (TM) | Schiller America, Inc. | 1990 | — |
| −4 | K984031 | Spirovit, Model SP-250 | Schiller AG | 1999 | — |
| −3 | K992823 | Spirovit SP-2, Pneumocheck II | Schiller AG | 2000 | — |
| −2 | K022276 | Kokomate | Ferraris Respiratory, Inc. | 2002 | — |
| −1 | K051572 | Koko Legend | Pulmonary Data Services, Inc. | 2005 | — |
| 0 (this device) | K100687 | Vitalograph Hand Held Spirometer, Model 2120 | Vitalograph (Ireland), Ltd. | 2010 | — |
| +1 | K200550 | Vitalograph Model 2120 In2itive eDiary | Vitalograph Ireland, Ltd. | 2020 | — |
| +2 | K212938 | Vitalograph Model 6000 Alpha | Vitalograph Ireland, Ltd. | 2022 | — |
| +1 | K142812 | Vitalograph Model 6800 Pneumotrac | Vitalograph (Ireland), Ltd. | 2015 | — |
| +3 | K251777 | MESI mTABLET SPIRO | Mesi D.O.O. | 2026 | — |
| +1 | K160253 | Vitalograph Model 6300 micro | Vitalograph (Ireland), Ltd. | 2016 | — |
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 |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K946075 | Vitalograph Model 2120Summary page 1…ass II (performance standards). 7. Predicate Device: Manufacturer :Vitalograph Device Name :2120 Hand Held Spirometer 5 10(k) No :K946075 Manufacturer :Cardinal Health Device Name :SpiroPro *510(k) No :K092324 8. Description… | 1995 |
| * | K092324 | SpiroproSummary page 1…:2120 Hand Held Spirometer 5 10(k) No :K946075 Manufacturer :Cardinal Health Device Name :SpiroPro *510(k) No :K092324 8. Description of Device: The Vitalograph Model 2120 is intended to be used, as its predecessor, as a battery operated spirome… | 2009 |
| * | K051572 | Koko LegendSummary page 3…Predicate Device - KoKo Legend Devices - Vitalograph Model Vitalograph 2120 K051 572 SpiroPro 2120 Specifications - K0923241… | 2005 |
| † | K912412 | Vitalograph Spirotrac Iii | 1991 |
| † | K854526 | Vitalograph Compact | 1985 |
| † | K873562 | Vitalograph-Alpha | 1988 |
| † | K925085 | Escort Spirometer | 1993 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K200550 (Vitalograph Ireland, Ltd., 2020) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K946075.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 device is a battery operated spirometer which measures three basic patient respiratory parameters {FVC, MVV and VC}. The model 2120 is a hand held spirometer designed for lung function testing in a variety of environments such as hospital wards, health centres and private homes. The model 2120 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/K100687 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100687: Vitalograph Hand Held Spirometer, Model 2120.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100687
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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