FDA 510(k) · Masimo
K061204: MASIMO SET RADICAL 7 PULSE CO-OXIMETER (Masimo Corporation)
Masimo Corporation received FDA 510(k) K061204 for MASIMO SET RADICAL 7 PULSE CO-OXIMETER, with a decision date of Jul 27, 2006 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K061204 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | MASIMO SET RADICAL 7 PULSE CO-OXIMETER |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | May 1, 2006 |
| Decision date | Jul 27, 2006 |
| 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
510(k) Number (if known): Device Name: Masimo SET Radical 7 CO-Oximeter Indications For Use: The Masimo SET® Radical 7 Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SP02), pulse rate (measured by an SP0 2 sensor), carboxyhemoglobin (measured by an SpCO/SpMet sensor), and/or methemoglobin saturation (measured by an SpCO/SpMet sensor). The Masimo SET® 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 SET® Radical 7 Pulse CO-Oximeter and accessories is indicated to provide the continuous noninvasive monitoring data obtained from the Masimno SET® Radical 7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (Sp 0 2) and pulse rate (measured by an Sp 0 2 sensor) to multi-parameter devices for the display of those devices. Prescription Use _X____ANDJ/OR Over-The-Counter Use (Per 21 GER 801 Subpart D) (Per 21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRHI, Office of Device Evaluation (ODE) cn of Anesthesiology~General Hospital, _,on Control, Dental Devices r !~R,-zo+
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 K061204
- K221260 CSF-3 (Cardiac Sense, Jan 6, 2023, DPS)
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.