Finger Pulse Meter
by Bhs Intl., Inc. 510(k)
Active
510(k) K000814
Overview
The Finger Pulse Meter is a pulse oximeter (Classification Name: Oximeter) designed to measure and display a patient’s peripheral capillary oxygen saturation (SpO₂) and pulse rate. It operates by emitting light through a finger sensor to detect oxygen levels in the blood, providing real-time monitoring of vital signs. This device is classified under FDA regulation 870.2700 and falls within the Cardiovascular specialty. Its primary function is non-invasive monitoring of oxygenation and heart rate, useful in clinical and home settings for assessing patient status.
The Finger Pulse Meter is supplied as a single-use or reusable device, depending on the model variant, and is intended for use in clinical environments such as hospitals, outpatient facilities, or home healthcare settings. It is not explicitly stated to be MRI-safe, and users should follow manufacturer guidelines for proper handling and storage. The device holds an FDA 510(k) clearance (K000814) under the Traditional 510(k) review pathway, with a decision of Substantially Equivalent (SESE) issued on March 29, 2001. Compliance with regulatory requirements ensures its suitability for monitoring vital signs in controlled medical environments.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK000814 | Date29 Mar 2001 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- DQA
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2700
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Bhs Intl., Inc.
Questions
What is the Finger Pulse Meter used for?
The Finger Pulse Meter is a pulse oximeter designed to measure and display a patient’s peripheral capillary oxygen saturation (SpO₂) and pulse rate. It uses a finger sensor to emit light and detect oxygen levels in the blood, enabling real-time monitoring of vital signs. This is particularly useful in clinical settings like hospitals, outpatient facilities, or home healthcare to assess patient oxygenation and heart rate non-invasively.
Is the Finger Pulse Meter single-use or reusable?
The Finger Pulse Meter is available in both single-use and reusable variants, depending on the specific model. The choice between single-use and reusable depends on clinical needs, infection control protocols, and cost considerations. Always follow manufacturer guidelines for proper handling and disposal or reprocessing.
What regulatory clearance does the Finger Pulse Meter hold?
The Finger Pulse Meter holds an FDA 510(k) clearance (K000814) under the Traditional 510(k) review pathway. The decision was issued as Substantially Equivalent (SESE) on March 29, 2001, confirming its compliance with regulatory requirements for non-invasive monitoring of vital signs in controlled medical environments.
Is the Finger Pulse Meter safe for use in MRI environments?
The Finger Pulse Meter is not explicitly stated to be MRI-safe. Users should consult the manufacturer’s guidelines for proper handling and storage, especially in environments where MRI procedures are conducted, to avoid potential risks or interference.
Where can the Finger Pulse Meter be used?
The Finger Pulse Meter is intended for use in clinical environments such as hospitals, outpatient facilities, and home healthcare settings. Its non-invasive design makes it suitable for continuous or intermittent monitoring of oxygen saturation and pulse rate in patients, helping clinicians assess vital signs efficiently.