FDA 510(k) · Masimo
K041815: LNCS OXIMETRY SENSORS (Masimo Corp.)
Masimo Corp. received FDA 510(k) K041815 for LNCS OXIMETRY SENSORS, with a decision date of Jul 29, 2004 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K041815 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corp. |
| Device name | LNCS OXIMETRY SENSORS |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Jul 6, 2004 |
| Decision date | Jul 29, 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): Device Name: LNCS Sensors and Cables Indications For Use: The LNCS Sensors and Cables are indicated for the continuous noninvasive monitoring of functional oxygen saturation 0 of arterial hemoglobin (Sp02) and pulse rate (measured by an SP 2 sensor) for use with adult, pediatric, infant, 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. 030" Prescription Use XX 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) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-W Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number _ k 0 1i (~I
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.
- K040259 MASIMO SET INTELLIVUE PULSE OXIMETER MO… (Masimo)
Later records that cite K041815
- K083622 LNCS OXIMETRY SENSORS (Masimo, Apr 2, 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.