# K954267: Burdick 200 Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Burdick, Inc.
- Decided: May 3, 1996 after 234 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. The FDA summary names its predicate without a number.
- (no number) Model 3302 Oximeter: named in the summary without a submission number
- (no number) BCI International Model 3200 Pulse Oximeter: named in the summary without a submission number

## Indications for use
The Burdick 200 Pulse Oximeter provides SpO2, Pulse Rate, and Pulse Strength measurements. It may be used in the hospital or clinical environment, during emergency land or air transport, or for in home use. The intended patient population is neonates to adults. The oximeter permits patient monitoring with adjustable alarm limits as well as visual and audible alarm signals.

Source page: https://510kreport.com/device/K954267
Methodology: https://510kreport.com/methodology