FDA 510(k) · Masimo
K201770: Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor (Masimo Corporation)
Masimo Corporation received FDA 510(k) K201770 for Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor, with a decision date of Sep 24, 2020 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K201770 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Jun 29, 2020 |
| Decision date | Sep 24, 2020 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Special |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The Rad-G Pulse Oximeter and Accessories are intended for the noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), Pulse Rate (PR), and Pleth Respiration Rate (RRp).
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.
Later records that cite K201770
- K212161 Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories (Masimo, Mar 6, 2023, MWI)
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.