FDA 510(k) · Masimo
K121912: E1 EAR SENSORS (Masimo Corporation)
Masimo Corporation received FDA 510(k) K121912 for E1 EAR SENSORS, with a decision date of Jul 24, 2012 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K121912 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | E1 EAR SENSORS |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Jul 2, 2012 |
| Decision date | Jul 24, 2012 |
| 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
The Masimo ElI Ear Sensor is indicated for single patient use for continuous noninvasive monitoring of fuinctional oxygen saturation of arterial hemoglobin (SpO2) 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. Specifications The modified El Ear Sensor in this submission has been shown in verification and clinical validation studies to provide an improvement in the oxygen saturation accuracy specification from ± 3.5% to + 2.5% (Apms) under no motion and both well- and poorly-perffised conditions. El Ear Sensor Accuracy Specifications (Apgs) Accuracy (A~.m5)/ Existing Device - K101031I Subject Device Conditions No mnotion/ SP 0 2: ± 3.5% SPO2:1A 2.5% Well-perfrsed Pulse Rate: 3 beats/minute Pulse Rate: 3 beats/minute No motion/ SPO 2: + 3.5% SP02: + 2.5% poorly-perfused Pulse Rate: 3 beats/minute Pulse Rate: 3 beats/minute
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 K121912
- K121914 MASIMO SET USPO2 PULSE OXIMETRY CABLE (Masimo, Sep 7, 2012, 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.