Titrator Model 10K
PMA P860035
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP860035 | Date17 Dec 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Titrator{tm} Model 10K
- Trade Name
- Titrator Model 10K
- Generic Name
- CONTROLLER, CLOSED-LOOP, BLOOD-PRESSURE
- PMA Number
- FDA Product Code
- LSX
- Device Class
- Class III
- Advisory Committee
- General Hospital
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Titrator Model 10K is a closed-loop blood pressure controller designed for general hospital use. It automatically regulates blood pressure through feedback mechanisms as indicated by its generic name and device classification.
Manufactured by Ivac Corporation in San Diego, California, this device was granted FDA Premarket Approval (PMA) on December 17, 1987, under PMA number P860035. It is classified as a Class III medical device under product code LSX.
Other devices from Ivac Corporation
Questions
AI-generated answers, 18 Sep 2026
What type of device is the Titrator Model 10K?
The Titrator Model 10K is a closed-loop blood pressure controller, as defined by its generic name and FDA classification under product code LSX for Controller, Closed-Loop, Blood-Pressure devices.
Who manufactures the Titrator Model 10K and where are they located?
The Titrator Model 10K is manufactured by Ivac Corporation, located at 10300 Campus Pt. Dr., San Diego, CA 92121, as stated in the applicant and address fields.
When did the Titrator Model 10K receive FDA approval?
The Titrator Model 10K received FDA Premarket Approval (PMA) on December 17, 1987, with decision date 1987-12-17 and PMA number P860035.