510(k) Report

FDA applicant

Hach Company

Elkhart, IN4 decisions2004–20170 recalls

FDA records 4 decisions for Hach Company (Elkhart, IN) from 2004 to 2017: 4 510(k) clearances. Most are in product codes JOJ (Indicator, Physical/Chemical Sterilization…) and PSX (Chlorine Meter). Its devices cite 3 predicates, 0 of them its own earlier devices. No 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2017

2007: 12017: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hach Company 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?

  • JOJIndicator, Physical/Chemical Sterilization Process1decision
  • PSXChlorine Meter1decision
  • FJDDetector, Leak, Blood1decision
  • LIFDialyzer Reprocessing System1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K070419Opaciden Opa Reagent StripsHach Company · 20071cites it

What has FDA decided for it lately?

  • K162471Hach CM130 Chlorine Monitoring SystemHach Company · 2017
  • K070419Opaciden Opa Reagent StripsHach Company · 2007
  • K042322Sterichek Blood Leak Reagent StripsHach Company · 2004
  • K040660Sterichek Glutaraldehyde Reagent StripsHach Company · 2004

All 4 as Hach Company →