510(k) · Cleared
ClearedSpirovit, Model SP-250
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schiller AG · BZG Spirometer, Diagnostic
Cleared on Apr 30, 1999 as substantially equivalent to K896120 (Schiller America, Inc., 1990) after a 169-day review. Its family tree reaches back 1 generation to 1990. 10 later devices descend from it.
- Decided
- Apr 30, 1999
- Review
- 169 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K896120 (1990). 10 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK896120 Schiller Model SP-100 Spirovit (TM)Schiller America, Inc. · 1990
- This deviceK984031 Spirovit, Model SP-250Schiller AG · 1999
- Descendant · cites it directly · 9 of its ownK992823 Spirovit SP-2, Pneumocheck IISchiller AG · 2000
- Descendant · 2 generations on · 8 of its ownK022276 KokomateFerraris Respiratory, Inc. · 2002
- Descendant · 3 generations on · 7 of its ownK051572 Koko LegendPulmonary Data Services, Inc. · 2005
- Descendant · 4 generations on · 6 of its ownK100687 Vitalograph Hand Held Spirometer, Model 2120Vitalograph (Ireland), Ltd. · 2010
- Descendant · 5 generations on · 2 of its ownK200550 Vitalograph Model 2120 In2itive eDiaryVitalograph Ireland, Ltd. · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K992823Spirovit SP-2, Pneumocheck IISchiller AG · 2000 · cites it directly9descendants
- K022276KokomateFerraris Respiratory, Inc. · 2002 · 2 generations on8descendants
- K051572Koko LegendPulmonary Data Services, Inc. · 2005 · 3 generations on7descendants
- K100687Vitalograph Hand Held Spirometer, Model 2120Vitalograph (Ireland), Ltd. · 2010 · 4 generations on6descendants
- K200550Vitalograph Model 2120 In2itive eDiaryVitalograph Ireland, Ltd. · 2020 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896120 | Schiller Model SP-100 Spirovit (TM) | Schiller America, Inc. | 1990 | — |
| 0 (this device) | K984031 | Spirovit, Model SP-250 | Schiller AG | 1999 | — |
| +1 | K992823 | Spirovit SP-2, Pneumocheck II | Schiller AG | 2000 | — |
| +2 | K022276 | Kokomate | Ferraris Respiratory, Inc. | 2002 | — |
| +3 | K051572 | Koko Legend | Pulmonary Data Services, Inc. | 2005 | — |
| +4 | K100687 | Vitalograph Hand Held Spirometer, Model 2120 | Vitalograph (Ireland), Ltd. | 2010 | — |
| +5 | K200550 | Vitalograph Model 2120 In2itive eDiary | Vitalograph Ireland, Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K896120 | Schiller Model SP-100 Spirovit (TM)Summary page 1…P-250 2. Common Name: Spirometer, Pulmonary Function Test Device A3 Legally Marketed Device Legally Marketed Uevice to which this submitted device is compared: SP-100 (K896120). A4 Intended Use The Spirovit SP-250 can be used to measure Forced Vital Capacity (FVC), Forced Expiratory Volume in one secon… | 1990 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992823 | Spirovit SP-2, Pneumocheck II | 2000 | 9 |
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?
- Its one ancestor has no recall.
- Of its descendants, K992823 (Schiller AG, 2000) has gone furthest, with 9 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.
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 Spirovit SP-250 can be used to measure Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1), FEV, (/JFVC, FEF 4,5, FEF 3759, FEF;545 PEF, FEF 5, FEFep, FEF sy, FIVC, FIV, JFIVC, PIF, FIF,,,, SVC, ERV, IRV, TV, MWV, MV, RR and TV, in patients 6 years of age or older.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984031 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984031: Spirovit, Model SP-250.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984031
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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