# K980299: Apex Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Marquette Medical Systems, Inc.
- Decided: Apr 24, 1998 after 87 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K891104 (1989). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K893221: Model 8500 Hand Held Pulse Oximeter, Nonin Medical, Inc. (1990) Summary page 2.
- K942248: Miniaturized Finger Clip Pulse Oximeter, Nonin Medical, Inc. (1994) Summary page 2.
- K891104: CD Telemetry Systems, Marquette Electronics, Inc. (1989) Summary page 2.

## Most influential descendants
- K080251: Apexpro Telemetry Systems (2008), 1 descendant of its own
- K160685: Surveyor S4 Mobile Monitor (2016), 0 descendants of its own

## Recalls of this device
- Sep 25, 2009 · Not classified · Z-0631-2010: Potential misuse of the ApexPro Telemetry System and incorrect message and alarm information in the ApexPro Operator's Manual may impact patient safety. When ApexPro Telemetry systems are used with Sp

## Indications for use
This device is viewed as a component of a system. The APEX Oximeter adds modularity to Marquette's CD Telemetry System product line. The Apex Oximeter is intended for portable patient monitoring of an ambulating patient's oxygen saturation and pulse rate. This device is infended to be used by personnel trained in the use of the equipment. It is infended to be used within the hospital/facility environment.

Source page: https://510kreport.com/device/K980299
Methodology: https://510kreport.com/methodology