FDA 510(k) · Masimo
K032551: MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR (Masimo Corp.)
Masimo Corp. received FDA 510(k) K032551 for MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR, with a decision date of Feb 19, 2004 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K032551 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corp. |
| Device name | MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Aug 19, 2003 |
| Decision date | Feb 19, 2004 |
| 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): K032551 Device Name: Masimo SET® Radical Pulse Oximeter with SatShareTM and the Masimo Series of Sensors and Cables Indications For Use: The following additional Masimo Sensor is indicated for the continuous noninvasive functional oxygen saturation of arterial hemoglobin (Sp0 2) and pulse rate: Reusable oximetry transflectance sensor intended for adults and pediatrics greater than 30 kg in hospitals, hospital-type facilities, mobile, and home environments. Prescription Use _ _X AND/OR Over-The-Counter Use 00 0 0 (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) Concurrence of CDRH, 0 fice of Device Evaluation (ODE) (vionSionr-O Div ion jesnesiology General Hospital, '; Infection Control, Dental Devices 510(k) Number: ~0 .-
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 K032551
- K160940 Masimo Disposable Transflectance Forehead Sensor (Masimo, Nov 23, 2016, 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.