510(k) · Cleared
ClearedHMS-5000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitalog Monitoring,Inc. · BZG Spirometer, Diagnostic
Cleared on Nov 19, 1991 after a 74-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 224 later devices descend from it.
- Decided
- Nov 19, 1991
- Review
- 74 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 0
224 later devices descend from it, 3 citing it directly.
- This deviceK914085 HMS-5000Vitalog Monitoring,Inc. · 1991
- Descendant · cites it directly · 138 of its ownK991045 Mini-Logger Series 2000Mini-Mitter Co., Inc. · 1999
- Descendant · 2 generations on · 132 of its ownK052489 ActiheartRespironics, Inc. · 2005
- Descendant · cites it directly · 100 of its ownK973920 StardustRespironics, Inc. · 1998
- Descendant · 3 generations on · 99 of its ownK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- Descendant · 3 generations on · 71 of its ownK113054 EquivitalHidalgo Limited · 2012
Showing 5 of 224 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 224 · See all- K991045Mini-Logger Series 2000Mini-Mitter Co., Inc. · 1999 · cites it directly138descendants
- K052489ActiheartRespironics, Inc. · 2005 · 2 generations on132descendants
- K973920StardustRespironics, Inc. · 1998 · cites it directly100descendants
- K061993Equivital, Model EQ-01Hidalgo Limited · 2006 · 3 generations on99descendants
- K113054EquivitalHidalgo Limited · 2012 · 3 generations on71descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914085 | HMS-5000 | Vitalog Monitoring,Inc. | 1991 | — |
| +1 | K991045 | Mini-Logger Series 2000 | Mini-Mitter Co., Inc. | 1999 | — |
| +2 | K052489 | Actiheart | Respironics, Inc. | 2005 | — |
| +1 | K973920 | Stardust | Respironics, Inc. | 1998 | — |
| +3 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| +3 | K113054 | Equivital | Hidalgo Limited | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 7 | 0 |
| 2012 | 6 | 0 |
| 2013 | 10 | 0 |
| 2014 | 9 | 0 |
| 2015 | 13 | 0 |
| 2016 | 9 | 0 |
| 2017 | 11 | 0 |
| 2018 | 8 | 0 |
| 2019 | 15 | 0 |
| 2020 | 17 | 0 |
| 2021 | 7 | 0 |
| 2022 | 18 | 0 |
| 2023 | 16 | 0 |
| 2024 | 17 | 0 |
| 2025 | 26 | 0 |
| 2026 | 13 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (224)
See all 2243 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?
- Of its descendants, K991045 (Mini-Mitter Co., Inc., 1999) has gone furthest, with 138 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 | — |
https://510kreport.com/device/K914085 · printed Nov 6, 2026
Cite this page
510(k) Report. “K914085: HMS-5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914085
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026