510(k) Report

FDA applicant

Tds Holdings, Inc.

Cleveland, OH1 decision2006–20069 recalls

FDA records 1 decision for Tds Holdings, Inc. (Cleveland, OH) in 2006: 1 510(k) clearance. All are in product code JWY (Manual Antimicrobial Susceptibility Test Systems). 9 recalls are linked to its devices, 9 Class I.

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 Tds Holdings, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tds Holdings, Inc. since 2007.

Recalls per year

9in 2022

2022: 9, 9 Class I
2007high 9 (2022) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • JWYManual Antimicrobial Susceptibility Test Systems1decision

What has FDA decided for it lately?

  • K060621Susceptibility Test Plate for Ertapenem 0.002-16UG/ML for Gram Negative. Susceptibility Test Plate for…Tds Holdings, Inc. · 20069 Class I recalls

The one decision as Tds Holdings, Inc. →

What has been recalled?

9 recalls linked to its devices; the latest:

  • K880641Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD ASTOct 20, 2022Class I
  • K880641Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD ASTOct 20, 2022Class I
  • K880641Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD ASTOct 20, 2022Class I
  • K880641Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD ASTOct 20, 2022Class I
  • K880641Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD ASTOct 20, 2022Class I
  • K880641Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD ASTOct 20, 2022Class I