# K981517: Cefdinir, 5 UG, Sensi-Disc

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Microbiology Systems
- Decided: Jun 9, 1998 after 42 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) Ciprofloxacin, 5 mcg, Sensi-Disc®: named in the summary without a submission number

## Indications for use
Use of BBL Cefdinir Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Cefdinir. Cefdinir has been shown to be aclive /n Vitro against most strains of microorganisms listed below, as described in the Parke-Davis package insert for this antimicrobic. Aerobic Gram-Pasitive Microorganisms Staphylococcus aureus (including B-lactamase producing stains, but excluding methicillin-resistant staphylococci) Staphylococcus epidermidis (methicillin-susceptible strains only) Aerobic Gram-Negative Microorganisms Haemophilus influenzae (including B-lactamase producing strains) Haemophilus parainfluenzae (including B-lactamase producing strains) Moraxella catarrhalis (including B-lactamase producing stains) Escherichia coli Kiebsiella pneumoniae Proteus mirabilis

Source page: https://510kreport.com/device/K981517
Methodology: https://510kreport.com/methodology