# K990960: Perimed Transcutaneous PO2 and PCO2 Monitor (PF5040)

- Pathway: 510(k) (Traditional)
- Applicant: Perimed, Inc.
- Decided: Sep 23, 1999 after 185 days
- Product code: LKD (Monitor, Carbon-Dioxide, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 868.2480
- 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) Novametrix TCOM Transcutaneous O₂/CO₂ Monitor: named in the summary without a submission number

## Indications for use
When installed in the Periflux System 5000, the Transcutaneous pO₂/pCO₂ Monitor (PF5040) is intended to monitor the levels of oxygen and/or carbon dioxide from tissue transcutaneously. The pO₂ monitor is intended only for use with infants not under gas anesthesia. The unit provides continuous, non-invasive monitoring of cutaneous oxygen and carbon dioxide. The Periflux System 5000 with the pO₂/pCO₂ module is intended to be used in hospitals and physician's offices. It is intended to monitor transcutaneous pCO₂ in adults and infants with and without gas anesthesia and pO₂ in infants not under gas anesthesia. The system is not intended for use by patients without the supervision of a physician.

Source page: https://510kreport.com/device/K990960
Methodology: https://510kreport.com/methodology