FDA 510(k) · Masimo
K040259: MASIMO SET INTELLIVUE PULSE OXIMETER MODULE (Masimo Corp.)
Masimo Corp. received FDA 510(k) K040259 for MASIMO SET INTELLIVUE PULSE OXIMETER MODULE, with a decision date of Apr 22, 2004 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K040259 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corp. |
| Device name | MASIMO SET INTELLIVUE PULSE OXIMETER MODULE |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Feb 4, 2004 |
| Decision date | Apr 22, 2004 |
| 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 Intellivue Pulse Oximeter Module Indications For Use: The Masimo SET® Intellivue Pulse Oximeter Module is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SPO2) and pulse rate (measured by an SP 0 2 sensor). The Masimo SET® Intellivue Pulse Oximeter is 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 and hospital-type facilities. Prescription Use _ _X AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (Per 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)- 0 Concurrence of CDRH, Office of Device Evaluation (ODE) (_ision Sign-Off Division of Anesthesiology. General Hospital, Infection Control, Dental Devices SIl0(k) Number. () j 0 7 5
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 K040259
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.