510(k) Report

FDA applicant

Kem Medical Products Corp.

Mchenry, IL4 decisions1980–20240 recalls

FDA records 4 decisions for Kem Medical Products Corp. (Mchenry, IL) from 1980 to 2024: 4 510(k) clearances. Most are in product codes JOJ (Indicator, Physical/Chemical Sterilization…) and FRC (Indicator, Biological Sterilization Process). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Kem Medical Products Corporation”.

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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Kem Medical Products Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2019: 12024: 1
2007high 1 (2019) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Kem Medical Products Corp.’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?

  • JOJIndicator, Physical/Chemical Sterilization Process3decisions
  • FRCIndicator, Biological Sterilization Process1decision

Whose devices does it build on?

Its devices cite 2 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.

  • K181788Lead-free Chemical Indicators for Steam SterilizationKem Medical Products Corp. · 20191cites it

What has FDA decided for it lately?

  • K241836Kem Medical Lead-free Chemical Indicators for Steam SterilizationKem Medical Products Corporation · 2024
  • K181788Lead-free Chemical Indicators for Steam SterilizationKem Medical Products Corp. · 2019
  • K802229Chemical Indicator - Kem Med & Bio SureKem Medical Products Corp. · 1980
  • K802228Biological Indicator - Kemmed & BiosureKem Medical Products Corp. · 1980

All 3 as Kem Medical Products Corp. →The one decision as Kem Medical Products Corporation →