510(k) Report

FDA applicant

Hardy Diagnostics

Santa Maria, CA110 decisions1993–20269 recalls

FDA records 110 decisions for Hardy Diagnostics (Santa Maria, CA) from 1993 to 2026: 110 510(k) clearances. Most are in product codes JTN (Susceptibility Test Discs, Antimicrobial) and JTO (Discs, Strips And Reagents, Microorganism…). Since 2016 its 510(k)s took a median of 57 days from receipt to decision, against 56 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 0 of them its own earlier devices. 9 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Hardy Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2008: 12010: 22011: 12015: 22016: 12017: 52018: 32019: 42020: 12023: 22024: 22025: 32026 (partial year): 2
2007high 5 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2015: 12019: 12020: 32021: 12025: 12026 (partial year): 1
2007high 3 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Hardy Diagnostics by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hardy Diagnostics’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • JTNSusceptibility Test Discs, Antimicrobial84decisions
  • JTODiscs, Strips And Reagents, Microorganism Differentiation10decisions
  • JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar5decisions
  • PQZGbs Culture Media, Selective And Differential3decisions
  • JSMCulture Media, Non-Propagating Transport3decisions
  • JTYCulture Media, For Isolation Of Pathogenic Neisseria3decisions

Also: JXC (1), LKS (1).

How long do its 510(k) reviews take?

Since 2016, its 19 510(k)s took a median of 57 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 56 days; 8 of its 19 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K193504HardyDisk AST Cefiderocol 30ug (FDC30)Hardy Diagnostics · 20201cites it
  • K172621HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)Hardy Diagnostics · 20171cites it
  • K192326HardyDisk AST Lefamulin 20µg (LMU20)Hardy Diagnostics · 20191cites it
  • K964560Bhi W/Vancomycin AgarHardy Diagnostics · 19971cites it
  • K160512HardyCHROM ESBLHardy Diagnostics · 20161cites it

What has FDA decided for it lately?

  • K262113HardyDisk AST Tebipenem 10µg (TBP10)Hardy Diagnostics · 2026
  • K260842HardyDisk AST Gepotidacin 10µg (GEP10)Hardy Diagnostics · 2026
  • K253105HardyDisk AST Cefiderocol 30µg (FDC30)Hardy Diagnostics · 20251 recall
  • K250956HardyDisk AST Gepotidacin 10µg (GEP10)Hardy Diagnostics · 2025
  • K250454HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)Hardy Diagnostics · 2025
  • K233534Viral Transport MediumHardy Diagnostics · 2024
  • K241060HardyDisk AST Cefiderocol 30µg (FDC30)Hardy Diagnostics · 2024
  • K231568HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)Hardy Diagnostics · 2023

All 110 as Hardy Diagnostics →

What has been recalled?

9 recalls linked to its devices; the latest:

  • K253105HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30g (FDC30)…Jun 8, 2026Class II
  • K190553HardyCHROM CRE, selective and differential culture medium for antimicrobial…May 6, 2025Class II
  • K960996HARDY DIAGNOSTICS CatScreen, 25dsk/vialDec 1, 2021Class II
  • K964560Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698…Dec 21, 2020Class II
  • K170586Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499Oct 6, 2020Class III
  • K170586Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage…Apr 20, 2020Class II

Other applicant names beginning “Hardy”

FDA records each applicant name separately; these may or may not be the same firm.

Hardy Media 114