FDA 510(k) · Masimo
K101031: MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1 (Masimo Corporation)
Masimo Corporation received FDA 510(k) K101031 for MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1, with a decision date of Nov 18, 2010 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K101031 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1 |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Apr 13, 2010 |
| Decision date | Nov 18, 2010 |
| 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
The Masimo Disposable Ear Sensors are indicated for single patient use for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SP02) and pulse rate (measured by an SP02 sensor) for use with adult and pediatric patients, (weighing >30kg), who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments. 510(k) Summary - Disposable Ear Oximnetry Sensors Page I of 2 510(k) SUMMARY Technology
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.
- K051212 MODIFICATION TO LNCS OXIMETRY SENSORS (Masimo)
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.