510(k) · Cleared
Recalled · Class II · 2023Multilab 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unetixs, Inc. · JAF Monitor, Ultrasonic, Nonfetal
Cleared on Apr 29, 1991 after a 217-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled 4 times.
- Decided
- Apr 29, 1991
- Review
- 217 days
- Class
- Class II
- Product code
- JAF
- Recalls
- 4
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK904392 Multilab 2000Unetixs, Inc. · 1991
- Descendant · cites it directly · 5 of its ownK111416 FalconViasonix, Ltd. · 2011
- Descendant · 2 generations on · 1 of its ownK131623 Smartdop XTKoven Technology, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK242662 Falcon/Xpress (Falcon/Xpress)Viasonix, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK233976 VasoGuard (V10, V8, V6, V4, V2)Corvascular Diagnostics, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK153762 Smartdop XT6Koven Technology, Inc. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K111416FalconViasonix, Ltd. · 2011 · cites it directly5descendants
- K131623Smartdop XTKoven Technology, Inc. · 2014 · 2 generations on1descendant
- K242662Falcon/Xpress (Falcon/Xpress)Viasonix, Ltd. · 2024 · 2 generations on0descendants
- K233976VasoGuard (V10, V8, V6, V4, V2)Corvascular Diagnostics, LLC · 2024 · 2 generations on0descendants
- K153762Smartdop XT6Koven Technology, Inc. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904392 | Multilab 2000 | Unetixs, Inc. | 1991 | — |
| +1 | K111416 | Falcon | Viasonix, Ltd. | 2011 | — |
| +2 | K131623 | Smartdop XT | Koven Technology, Inc. | 2014 | — |
| +2 | K242662 | Falcon/Xpress (Falcon/Xpress) | Viasonix, Ltd. | 2024 | — |
| +2 | K233976 | VasoGuard (V10, V8, V6, V4, V2) | Corvascular Diagnostics, LLC | 2024 | — |
| +3 | K153762 | Smartdop XT6 | Koven Technology, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2024 | 2 | 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 JAF? 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 JAF device
- #1 K242487 Laminar P1 (LDH-HW-001)score 10.3 · 7 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111416 | Falcon | 2011 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 10, 2023 | Class II | Z-1196-2023 | Use error | The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism. |
| Feb 10, 2023 | Class II | Z-1194-2023 | Use error | The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism. |
| Feb 10, 2023 | Class II | Z-1193-2023 | Use error | The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism. |
| Feb 10, 2023 | Class II | Z-1195-2023 | Use error | The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K111416 (Viasonix, Ltd., 2011) has gone furthest, with 5 descendants of its own.
How does its category compare?
All JAF devicesJAF Monitor, Ultrasonic, Nonfetal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAF
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JAF
Too few JAF 510(k)s in any year since 2007 to give a median.
Recalls per year · JAF
No recall names JAF since 2007.
Adverse event reports per year · JAF
1in 2023
MAUDE reports naming product code JAF, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 1 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 44 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K904392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K904392: Multilab 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K904392
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