FDA 510(k) · Masimo
K101896: MASIMO LNCS/M-LNCS OXIMETRY SENSORS (Masimo Corporation)
Masimo Corporation received FDA 510(k) K101896 for MASIMO LNCS/M-LNCS OXIMETRY SENSORS, with a decision date of Oct 21, 2010 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K101896 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | MASIMO LNCS/M-LNCS OXIMETRY SENSORS |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Jul 7, 2010 |
| Decision date | Oct 21, 2010 |
| 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
OCT 2 51 0(k) Number (if known): ________2010__ Device Name: Masimo LNCS/M-LNCS Oximetry Sensors Indications For Use: of functional The LNCS/M-LNCS Sensors are indicated for the continuous noninvasive monitoring by an SP02 sensor) for oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured conditions, no motion and motion use with adult, pediatric, infant, and neonatal patients during both and hospital-type facilities, mobile, and for patients who are well or poorly perfused in hospitals, 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) IF NEEDED) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE Concurrence of CDRH, Office of Device Evaluation (ODE) l Ae~tBSOIOV'General HOSP~tB Div~i~l inlctiP cntrlDental Devices 510(k) Number:d 510(k) Special, LNCS/M-LNCS Sensors Masimno, 7/6/2010 peas 15 of 254
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 K101896
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.