FDA 510(k) · Masimo
K182887: Masimo Rad-67 Pulse CO-Oximeter and Accessories (Masimo Corporation)
Masimo Corporation received FDA 510(k) K182887 for Masimo Rad-67 Pulse CO-Oximeter and Accessories, with a decision date of Mar 22, 2019 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K182887 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | Masimo Rad-67 Pulse CO-Oximeter and Accessories |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Oct 15, 2018 |
| Decision date | Mar 22, 2019 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
Indications For Use: Masimo Rad-67™ Pulse CO-Oximeter The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are intended for use in clinical and non-clinical settings. The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are indicated for non-invasive spot-check monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients who are well or poorly perfused during both motion and no motion conditions. The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are indicated for non-invasive spot-check monitoring of total hemoglobin concentration (SpHb®) for adult patients. rainbow DCI-mini sensor The rainbow DCI-mini sensor is intended for use in clinical and non-clinical settings. The rainbow DCI-mini sensor is indicated for non-invasive spot-check monitoring and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients who are well or poorly perfused during both motion and no motion conditions. The rainbow DCI-mini sensor is indicated for non-invasive spot-check monitoring of total hemoglobin concentration (SpHb®) for adult patients.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DQA is "Oximeter", class 2, 21 CFR 870.2700.
Our labels for filtering: claim SpO2 / pulse oximetry, sensor Finger PPG. These are heuristics, not FDA fields.