FDA 510(k) · Masimo
K053269: MASIMO SET RAD-8 PULSE OXIMETER (Masimo Corporation)
Masimo Corporation received FDA 510(k) K053269 for MASIMO SET RAD-8 PULSE OXIMETER, with a decision date of Dec 21, 2005 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K053269 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | MASIMO SET RAD-8 PULSE OXIMETER |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Nov 23, 2005 |
| Decision date | Dec 21, 2005 |
| 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: Masimo SET® Rad-8 Pulse Oximeter Indications For Use: The Masimo SET® Rad-8 Pulse Oximeter is indicated for the continuous noninvasive monitoring of functional SET® oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo for use with adult, pediatric, and neonatal patients during both no motion and Rad-8 Pulse Oximeter is indicated who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and motion conditions, for patients home environments. Prescription Use __ X AND/OR Over-The-Counter Use (Per 21 CFR 801.109 Subpart D) (Per 21 CFR 801.109 Subpart C) NEEDED) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF Concurrence of CDRH, Office of Device Evaluation (ODE) 0LA
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
No predicate numbers were parsed for this record. The FDA summary, if available, names the predicate.
Later records that cite K053269
- K092838 MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 (Masimo, Oct 15, 2009, DQA)
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.