Burton Applanation Tonometer - Model T850 & T1000
by R.H. Burton Co. 510(k)
Active
510(k) K924777
Overview
The Burton Applanation Tonometer – Models T850 & T1000 is a medical device classified as an applanation tonometer, used to measure intraocular pressure (IOP) in the eye. Applanation tonometry applies a known force to flatten a defined area of the cornea, enabling precise assessment of IOP—a critical diagnostic parameter in conditions such as glaucoma. These models are designed for clinical ophthalmic use, providing accurate readings to aid in the evaluation and management of ocular health.
The device is supplied as an ac-powered instrument, intended for use in ophthalmic examination settings. It is classified under FDA product code HKX and falls under Class II – Special Controls regulatory designation, with an FDA 510(k) clearance (K924777) granted in 1993. The models T850 and T1000 are reusable, non-sterile diagnostic tools, and their use adheres to standard ophthalmic practice guidelines. No MRI safety or sterility requirements are specified beyond routine clinical disinfection protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK924777 | Date5 Apr 1993 | 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- Withdrawn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
- HKX
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.1930
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Other devices from R.H. Burton Co.
Questions
What is the Burton Applanation Tonometer (Models T850 & T1000) used for?
The Burton Applanation Tonometer (Models T850 & T1000) is designed to measure intraocular pressure (IOP) in the eye using applanation tonometry. This method applies a controlled force to flatten a specific corneal area, enabling precise assessment of IOP—a critical diagnostic parameter for conditions like glaucoma. Accurate IOP readings help clinicians evaluate and manage ocular health effectively.
How is the Burton Applanation Tonometer supplied and powered?
The device is supplied as an ac-powered instrument, meaning it requires a standard electrical outlet for operation. It is intended for use in ophthalmic examination settings, such as clinics or hospitals, where reliable IOP measurements are essential for patient care.
Are the T850 and T1000 models reusable or single-use?
The Burton Applanation Tonometer (Models T850 & T1000) is classified as a reusable diagnostic tool. However, it is non-sterile and must adhere to standard ophthalmic practice guidelines for disinfection between uses. Proper cleaning and maintenance are required to ensure accuracy and prevent cross-contamination.
What are the key specifications or features of these models?
The device is FDA-cleared (510(k) K924777) and classified under product code HKX as a Class II medical device. It operates on ac power and is intended for clinical use in ophthalmology. No MRI safety or sterility requirements beyond routine disinfection are specified, and it is designed for long-term use in diagnostic settings.
How should the Burton Applanation Tonometer be stored?
While the device itself does not require specialized storage conditions beyond standard clinical environments, it should be kept in a clean, dry location to prevent damage or contamination. Follow manufacturer guidelines for maintenance and calibration to ensure consistent performance. Avoid exposure to extreme temperatures or humidity.