# K853018: Model 3000 Opticath Computer

- Pathway: 510(k) (Traditional)
- Applicant: Oximetrix, Inc.
- Decided: Jan 13, 1986 after 180 days
- Product code: DXG (Computer, Diagnostic, Pre-Programmed, Single-Function)
- Device class: 2
- Regulation: 21 CFR 870.1435
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K021874: Abbott Q2 Plus S02/Continuous Cardiac Output Computer, List Number 56711 (2002), 2 descendants of its own
- K152006: Cogent Hemodynamic Monitoring System (2016), 1 descendant of its own
- K232048: Cogent™ Hemodynamic Monitoring System; Cogent™ HMS (2023), 0 descendants of its own

## Recalls of this device
- Aug 11, 2009 · Not classified · Z-0143-2010: Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Aug 11, 2009 · Not classified · Z-0144-2010: Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock hazard.

Source page: https://510kreport.com/device/K853018
Methodology: https://510kreport.com/methodology