BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)
FDA 510(k) K221826 · Becton, Dickinson and Company
510(k) numberK221826
Submission
- Device name
- BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)
- Applicant
- Becton, Dickinson and Company
Sparks, MD, US - Received
- June 23, 2022
- Decision date
- December 21, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JTN – Susceptibility Test Discs, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1620
- Specialty
- Microbiology
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| K261781 | Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60JTN · Traditional | Thermo Fisher Scientific (Oxoid Ltd.) | 07/24/2026SE |
| K261853 | Gepotidacin GEP 10 µgJTN · Traditional | Liofilchem, Inc. | 07/23/2026SE |
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| K251337 | Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10JTN · Traditional | Thermo Fisher Scientific (Oxoid Ltd.) | 12/05/2025SE |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30)JTN · Traditional | Hardy Diagnostics | 11/20/2025SE |
| K251879 | Sulopenem SPM 2 µgJTN · Traditional | Liofilchem | 08/12/2025SE |
| K250956 | HardyDisk AST Gepotidacin 10µg (GEP10)JTN · Traditional | Hardy Diagnostics | 06/26/2025SE |
| K250885 | Ceftobiprole BPR 5 µg DiscJTN · Traditional | Liofilchem, Inc. | 06/23/2025SE |
| K250789 | Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50JTN · Traditional | Thermo Fisher Scientific (Oxoid Ltd.) | 06/12/2025SE |
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Questions and answers
When was BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) cleared by the FDA?
BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) (K221826) received a 510(k) decision of Substantially Equivalent on December 21, 2022, 181 days after the submission was received.
What is the product code of K221826?
The FDA product code is JTN – Susceptibility Test Discs, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1620.