# K003004: Oscar 2, Model 222

- Pathway: 510(k) (Special)
- Applicant: Suntech Medical Instruments, Inc.
- Decided: Oct 25, 2000 after 30 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
146 later devices descend from it; 7 cite it directly.
0 of 147 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
- K013319: Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor (2002), 124 descendants of its own
- K041156: Avant Digital Pulse Oximetry System, Models 4000, 4001 (2004), 89 descendants of its own
- K043359: 4100 Patient Oximeter Module (2005), 75 descendants of its own
- K031487: Model Avant 2120 Pulse Oximeter and Nibp (2004), 42 descendants of its own
- K081285: Finger Pulse Oximeter, Model 9560 (2008), 40 descendants of its own

Source page: https://510kreport.com/device/K003004
Methodology: https://510kreport.com/methodology