510(k) Report

FDA applicant

Binx Health, Inc.

Boston, MA2 decisions2019–20201 recall

FDA records 2 decisions for Binx Health, Inc. (Boston, MA) from 2019 to 2020: 2 510(k) clearances. All are in product code QEP (Nucleic Acid Detection System For Non-Viral…). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 recall is 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 Binx Health, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2019: 12020: 1
2019high 1 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2019high 1 (2023) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Binx Health, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • QEPNucleic Acid Detection System For Non-Viral Microorganism (S) Causing Sexually…2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K191352binx health io CT/NG AssayBinx Health, Inc. · 20191cites it

What has FDA decided for it lately?

  • K200533binx io CT/NG Assay and binx io CT/NG SystemBinx Health, Inc. · 20201 recall
  • K191352binx health io CT/NG AssayBinx Health, Inc. · 2019

All 2 as Binx Health, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K200533binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia…Mar 29, 2023Class II