INTERCEPT
by Vital Signs, Inc. 510(k)
Active
510(k) K843591
Overview
The device is a Regulator, Vacuum, classified under medical specialty General Hospital. It is identified by the product code KDP and regulation number 880.6740.
It received FDA 510(k) clearance under K843591 on October 19, 1984, following a traditional review process. The device is classified as Class II and was determined to be substantially equivalent.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK843591 | Date19 Oct 1984 | 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- Withdrawn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
- KDP
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6740
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Vital Signs, Inc.
Questions
What is the INTERCEPT Regulator, Vacuum used for?
The INTERCEPT Regulator, Vacuum is a medical device designed for general hospital applications, specifically to regulate vacuum pressure in clinical settings as indicated by its product code KDP and regulation number 880.6740.
How was the INTERCEPT Regulator, Vacuum authorized for market release?
The device received FDA 510(k) clearance under submission K843591 on October 19, 1984, following a traditional review process, and was determined to be substantially equivalent to a legally marketed predicate device.
What regulatory classification does the INTERCEPT Regulator, Vacuum hold?
The INTERCEPT Regulator, Vacuum is classified as a Class II medical device by the FDA, based on its submission under 510(k) K843591 and its product code KDP under regulation 880.6740 for general hospital use.