Gould Xcaliber
by Bio-Tek Instruments, Inc. 510(k)
Active
510(k) K862344
Overview
The Gould Xcaliber Transducer Calibration System is an extravascular blood-pressure transducer designed for calibrating and verifying the accuracy of pressure transducers used in physiological monitoring and hemodynamic measurements. It serves as a precision reference standard to ensure consistent performance in clinical and research settings, particularly within cardiovascular applications.
This device is supplied as a reusable instrument and is intended for use in clinical environments where transducer calibration is required. It operates within the regulatory framework of a traditional 510(k) clearance under the FDA’s classification as a Class II medical device (DRS product code). The system is not indicated for direct patient use but rather as a calibration tool for maintaining the integrity of monitoring equipment.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK862344 | Date6 Aug 1986 | 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- Withdrawn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
- DRS
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2850
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Bio-Tek Instruments, Inc.
Questions
What is the Gould Xcaliber primarily used for in a clinical setting?
The Gould Xcaliber is an extravascular blood-pressure transducer calibration system designed specifically to verify and calibrate the accuracy of pressure transducers used in physiological monitoring and hemodynamic measurements. It ensures consistent performance of monitoring equipment in cardiovascular applications, such as intensive care units or research settings, but is not intended for direct patient use.
Is the Gould Xcaliber a single-use or reusable device?
The Gould Xcaliber is supplied as a reusable instrument, meaning it is intended for repeated use in clinical environments where transducer calibration is required. Proper cleaning and maintenance procedures should be followed to ensure its continued accuracy and reliability.
How was the regulatory approval for the Gould Xcaliber obtained?
The Gould Xcaliber received FDA clearance through a traditional 510(k) pathway, classified as a Class II medical device under the product code DRS. The submission was reviewed by the Cardiovascular (CV) Advisory Committee in 1986, with a decision of Substantially Equivalent (SESE) granted on August 6, 1986.
What type of clinical environments would benefit most from using the Gould Xcaliber?
The Gould Xcaliber is particularly useful in clinical environments where precise hemodynamic monitoring is critical, such as cardiovascular intensive care units, operating rooms, or research laboratories. Its role is to maintain the accuracy of blood-pressure transducers used for patient monitoring, ensuring reliable data for clinical decisions.
Does the Gould Xcaliber require any special storage conditions?
While the device data does not specify exact storage conditions, as a reusable calibration instrument, the Gould Xcaliber should be stored in a clean, dry environment to prevent contamination or damage. Proper handling and maintenance procedures should be followed to preserve its functionality and accuracy over time.