# K980879: Oscillomate Nibp / SP02 Ems Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Cas Medical Systems, Inc.
- Decided: Jul 16, 1998 after 129 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K910772 (1991). 4 ancestors in all.
426 later devices descend from it; 2 cite it directly.
1 of 431 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972020: Oscillomate Non-Invasive Blood Pressure Monitor, Cas Medical Systems, Inc. (1998). Cleared while this submission was under review Summary page 2.
- K893221: Model 8500 Hand Held Pulse Oximeter, Nonin Medical, Inc. (1990) Summary page 2.

## Most influential descendants
- K982776: 9303 Neonatal/Adult Vital Signs Monitor (1998), 425 descendants of its own
- K033048: Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS (2004), 272 descendants of its own
- K050844: 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL (2005), 264 descendants of its own
- K060065: CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor (2006), 250 descendants of its own
- K072295: Capnostream 20 with A2 Adaptive Averaging Software (2007), 197 descendants of its own

## Indications for use
The Oscillomate 9002 NIBP / Sp02 Monitor Non-invasively measures blood pressure, oxygen saturation and the pulse of the adult and pediatric patient in EMS environments by health care professionals. It is not designed for continuous unsupervised monitoring.

Source page: https://510kreport.com/device/K980879
Methodology: https://510kreport.com/methodology