Bio-Tek Ear Oximeter
by Bio-Tek Instruments, Inc. 510(k)
Active
510(k) K810363
Overview
The Bio-Tek Ear Oximeter is an extravascular pulse oximetry device designed to measure blood oxygen saturation by transmitting light through the ear. It operates by detecting the amount of reflected or scattered light at specific wavelengths, correlating this data to hemoglobin oxygenation levels. This non-invasive monitoring tool is classified as a Class II medical device under FDA regulations.
The device is supplied as a reusable clinical instrument and is intended for use in cardiovascular monitoring settings. It requires no sterilisation for single-patient use but may be cleaned and disinfected between uses per manufacturer guidelines. The ear probe sensor (e.g., Model K942752 referenced in related submissions) attaches to the ear for measurement. Authorised under FDA 510(k) clearance (K810363) with a product code of DPZ, compliance is governed by regulation 870.2710.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK810363 | Date27 Feb 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Ear Oximeter
- 510(k) Number
- FDA Product Code
- DPZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2710
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Bio-Tek Instruments, Inc.
Questions
What is the Bio-Tek Ear Oximeter used for?
The Bio-Tek Ear Oximeter is a non-invasive, extravascular pulse oximetry device designed to measure blood oxygen saturation (SpO₂) by transmitting light through the ear. It detects reflected or scattered light at specific wavelengths to estimate hemoglobin oxygenation levels, making it useful for continuous cardiovascular monitoring in clinical settings.
Is the Bio-Tek Ear Oximeter single-use or reusable?
The Bio-Tek Ear Oximeter is supplied as a reusable clinical instrument. While it does not require sterilization for single-patient use, it can be cleaned and disinfected between uses following the manufacturer’s guidelines to maintain safety and functionality.
How is the ear probe sensor attached, and what models are referenced?
The ear probe sensor attaches directly to the ear for measurement. The device description references the Model K942752 as part of related submissions, though this may not be the only available model. For precise specifications, consult the manufacturer’s documentation or catalog.
Does the Bio-Tek Ear Oximeter require sterilization?
No sterilization is required for single-patient use. However, the device must be cleaned and disinfected between uses to prevent cross-contamination and ensure reliable performance. Adhere to the manufacturer’s cleaning protocols for optimal hygiene.
What regulatory pathway does the Bio-Tek Ear Oximeter follow?
The Bio-Tek Ear Oximeter is authorized under the FDA’s 510(k) clearance process (K810363) and classified as a Class II medical device. It complies with regulation 870.2710, which governs oximeters, and is intended for use in cardiovascular monitoring settings.