# K904392: Multilab 2000

- Pathway: 510(k) (Traditional)
- Applicant: Unetixs, Inc.
- Decided: Apr 29, 1991 after 217 days
- Product code: JAF (Monitor, Ultrasonic, Nonfetal)
- Device class: 2
- Regulation: 21 CFR 892.1540
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K111416: Falcon (2011), 5 descendants of its own
- K131623: Smartdop XT (2014), 1 descendant of its own
- K242662: Falcon/Xpress (Falcon/Xpress) (2024), 0 descendants of its own
- K233976: VasoGuard (V10, V8, V6, V4, V2) (2024), 0 descendants of its own
- K153762: Smartdop XT6 (2016), 0 descendants of its own

## Recalls of this device
- Feb 10, 2023 · Class II · Z-1196-2023: 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: 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: 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: 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.

Source page: https://510kreport.com/device/K904392
Methodology: https://510kreport.com/methodology