510(k) · Cleared
ClearedVitalograph Model 6600 Compact
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 Jun 30, 2015 as substantially equivalent to K141546 (Vitalograph (Ireland), Ltd., 2014) and 1 other predicate after a 286-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Jun 30, 2015
- Review
- 286 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K896120 (1990). 33 ancestors in all, the oldest K831779 (1983). No later device cites it as a predicate yet.
- 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 deviceK142642 Vitalograph Model 6600 CompactVitalograph (Ireland), Ltd. · 2015
View 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) | K142642 | Vitalograph Model 6600 Compact | Vitalograph (Ireland), Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 2000 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 1 | 0 |
| 2014 | 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? (2)
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 |
|---|---|---|---|
| * | K141546 | Vitalograph Model 7000 SpirotracSummary page 5…ied per 21 CFR 868.1840. Product Code BZG. 7. Predicate Device: Manufacturer : Vitalograph Device Name : Model 7000 Spirotrac 510(k) No : K141546, Class 2, Product Code BZG. Manufacturer : Vitalograph Device Name : Model 2120 510(k) No : K1006… | 2014 |
| * | K100687 | Vitalograph Hand Held Spirometer, Model 2120Summary page 5…7000 Spirotrac 510(k) No : K141546, Class 2, Product Code BZG. Manufacturer : Vitalograph Device Name : Model 2120 510(k) No : K100687, Class 2, Product Code BZG. 8. Description of Device: Vitalograph Model 6600 Compact, running Vitalograph Model 7000 Spirotrac… | 2010 |
| † | K942779 | Disposable Bacteriological Filter | 1994 |
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 25 years and passes through 5 companies; a new generation was cleared every 4.7 years on median.
- None of the 33 ancestors has a recall.
- 1 other device also cites its predicate K141546.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 6600 COMPACT is intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on adults and paediatrics, 5 years and older. The device is intended to be used as a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC or connected to compatible Vitalograph or third party devices to acquire, view, store and print the device output.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142642: Vitalograph Model 6600 Compact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142642
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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