FDA 510(k) · Masimo
K051439: LNOP BLUE OXIMETRY SENSOR (Masimo Corporation)
Masimo Corporation received FDA 510(k) K051439 for LNOP BLUE OXIMETRY SENSOR, with a decision date of Jul 15, 2005 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K051439 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | LNOP BLUE OXIMETRY SENSOR |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Jun 2, 2005 |
| Decision date | Jul 15, 2005 |
| 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: LNOP Blue Indications For Use: The LNOP Blue Sensors are indicAted for'the continuous noninvasive monitoring' of fallutional oxygen saturation of arterial hemoglobin (Sp 0 2) and pulse rate (measured by an SP 0 2sensor) for use with pediatric, infant, and neonatal patients with congenital cyanotic cardiac lesions in hospitals, hospital-type facilities, mobile, and home environments. Prescription Use X__ AND/OR Over-The-Counter Use 008 (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-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: I< OE5 (
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.
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.