# K973991: Metron QA-510 SPO2 Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Metron U.S., Inc.
- Decided: Jan 16, 1998 after 87 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Metron U.S. Q4-510 SpO2 Analyzer is a precision instrument designed to perform tests on Pulse Oximeters. It also performs important measurements, such as the quality of the infrared LED and Red LED. The QA-510 is designed to be used by trained service technicians.

Source page: https://510kreport.com/device/K973991
Methodology: https://510kreport.com/methodology