FDA 510(k) · Masimo
K092838: MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 (Masimo Corporation)
Masimo Corporation received FDA 510(k) K092838 for MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8, with a decision date of Oct 15, 2009 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K092838 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Sep 15, 2009 |
| Decision date | Oct 15, 2009 |
| 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 and Accessories Indications For Use: The Masimo SET® Rad-8 Pulse Oximeter and Accessories are. indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2) and pulse rate (measured by an SPO2 sensor). The Masimo SET® Rad-8 Pulse Oximeter and Accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, for patients who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and 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) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (DMidion Sign-Off) Division of Anesthesiology, General Hospital Infection-Control, Dental Devices 510(k) Number: Ico © ?- .. ' Masimo Special 510(k) Rad8 w/ 300 bpm, 9/14109
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.
- K053269 MASIMO SET RAD-8 PULSE OXIMETER (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.