FDA 510(k) · Masimo
K051212: MODIFICATION TO LNCS OXIMETRY SENSORS (Masimo Corporation)
Masimo Corporation received FDA 510(k) K051212 for MODIFICATION TO LNCS OXIMETRY SENSORS, with a decision date of Jul 12, 2005 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K051212 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | MODIFICATION TO LNCS OXIMETRY SENSORS |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | May 11, 2005 |
| Decision date | Jul 12, 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: LNCS Sensors Indications For Use: n monitoring of functional-oexyge saturation of arterial The LNCS Sensors are indicated for-the continuous noninvasive sensor) for use with adult, pediatric, infant, and neonatal hemoglobin (SpO2) and pulse rate (measured by an SpO2 and for patients who are well or poorly perfused in hospitals, patients during both no motion and motion conditions, hospital-type facilities, mobile, and home environments. AND/OR Over-The-Counter Use Prescription Use X_ (Per 21 CFR 807 Subpart C) (Per 21 CFR 801 Subpart D) ON ANOTHER PAGE IF NEEDED) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE (ODE) Concurrence of CDRH, Office of Device Evaluation (Division Sign-Off) Division of Aqg~thetio:Y, General Hospital, Infoetlon Coftro!, Dental Devices M1O(k) Numor.. 009
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 K051212
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.