# K082853: Clinical Oxygen Dose Recorder (Codr), Model 300-CR

- Pathway: 510(k) (Traditional)
- Applicant: Inspired Technologies, Inc.
- Decided: Mar 23, 2009 after 175 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K962603 (1997). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051313: BI-Naps Nasal Airflow and Snore Transducer, Salter Labs (2005) Summary page 1.
- K061996: Sandman Pocket, Eb Neuro S.P.A. (2006) Summary page 1.

## Indications for use
The Clinical Oxygen Dose Recorder (CODR) Model 300-CR records heart rate and oxygen saturation data provided by a Pulse oximeter; flow and pressure data from the oxygen delivery system; and measures breath rate and inhale/exhale ratio (I:E ratio) by monitoring the flow in the oxygen delivery tubing. Data is presented to enable the clinician to view the effects of the oxygen device's delivery performance on a patient in different ambulatory settings, i.e., rest and exercise. It is not to be used as a diagnostic tool. The CODR is intended to be used by trained clinicians in the hospital, clinical or home care environments. For the patient population the CODR will have the same indications for use as the oxygen-source to which it is attached.

Source page: https://510kreport.com/device/K082853
Methodology: https://510kreport.com/methodology