FDA 510(k) · Masimo
K110028: MASIMO RADICAL Y PULSE CO-OXIMETER (Masimo Corporation)
Masimo Corporation received FDA 510(k) K110028 for MASIMO RADICAL Y PULSE CO-OXIMETER, with a decision date of Mar 17, 2011 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K110028 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | MASIMO RADICAL Y PULSE CO-OXIMETER |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Jan 5, 2011 |
| Decision date | Mar 17, 2011 |
| 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
510(k) Number (if known): Device Name: Radical 7 Pulse CO-Oximeter and Accessories Indications For Use: The Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated to provide the continuous noninvasive monitoring data obtained from the Masimo Radical 7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SPO2) and pulse rate to multi- parameter devices for the display of those devices. Prescription Use ___X AND/OR Over-The-Counter Use _____ (Per 21 CFR 8O1.109 Subp~art 0) (Per 21 CFR 801.109 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Ea Eval ati (Division S0i ii)th infect~lon 17trol, Dental Devices Special 510(k), Radical 71Q)Nme: tI ' 0110312011, Page 4-1
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.
- K100428 MASIMO RAINBOW SET RADICAL 7R PULSE CO-… (Masimo)
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.