# K965159: Cetibuten, 30MCG, Sensi-Disc

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Microbiology Systems
- Decided: Feb 4, 1997 after 43 days
- Product code: JTN (Susceptibility Test Discs, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 866.1620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Other BBL® Sensi-Discs®, such as Cefixime, 5 mcg, Sensi-Disc®: named in the summary without a submission number

## Indications for use
Use of BBL® Ceftibuten Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Ceftibuten.

Source page: https://510kreport.com/device/K965159
Methodology: https://510kreport.com/methodology