510(k) · Cleared
ClearedVitalograph Model 6300 micro
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 Aug 26, 2016 as substantially equivalent to K100687 (Vitalograph (Ireland), Ltd., 2010) and 1 other predicate after a 207-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Aug 26, 2016
- Review
- 207 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K896120 (1990). 18 ancestors in all, the oldest K831779 (1983). No later device cites it as a predicate yet.
- 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 backK142812 Vitalograph Model 6800 PneumotracVitalograph (Ireland), Ltd. · 2015
- This deviceK160253 Vitalograph Model 6300 microVitalograph (Ireland), Ltd. · 2016
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 | K142812 | Vitalograph Model 6800 Pneumotrac | Vitalograph (Ireland), Ltd. | 2015 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K100687 | Vitalograph Hand Held Spirometer, Model 2120Summary page 5…ic Spirometer as classified per 21 CFR 868.1840. Product Code BZG. 3. Predicate Device: Manufacturer : Vitalograph Device Name : Model 2120 510(k) No : K100687, Class 2, Product Code BZG. Classified per 21 CFR 868.1840 Manufacturer : Vitalograph Device Name : Mode… | 2010 |
| * | K142812 | Vitalograph Model 6800 PneumotracSummary page 5…0687, Class 2, Product Code BZG. Classified per 21 CFR 868.1840 Manufacturer : Vitalograph Device Name : Model 6800 Pneumotrac 510(k) No : K142812, Class 2, Product Code BZG. Classified per 21 CFR 868.1840 4. Description of Device: Vitalograph Model 630… | 2015 |
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 26 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- None of the 18 ancestors has a recall.
- 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. 2016, 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 spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The Vitalograph micro is a handheld spirometer designed for lung function testing for use on adults and pediatrics, 5 years and older, in a variety of environments such as hospital wards, health centers and private homes under the supervision of a healthcare provider.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160253: Vitalograph Model 6300 micro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160253
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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