510(k) Report

FDA applicant

Medical Specialties, Inc.

Mchenry, IL40 decisions1979–19951 recall

FDA records 40 decisions for Medical Specialties, Inc. (Mchenry, IL) from 1979 to 1995: 40 510(k) clearances. Most are in product codes JPK (Mixture, Hematology Quality Control) and KRZ (Calibrator For Hemoglobin And Hematocrit…). 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, clinical chemistry panel, where it files most

How often FDA has decided Medical Specialties, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Specialties, Inc. since 2007.

Recalls per year

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medical Specialties, 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?

  • JPKMixture, Hematology Quality Control5decisions
  • KRZCalibrator For Hemoglobin And Hematocrit Measurement3decisions
  • CHDAcid, Ferric Ion-Sulfuric, Cholesterol1decision
  • KNKAcid, Uric, Uricase (Colorimetric)1decision
  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency1decision
  • JHMColorimetric Method, Lipoproteins1decision

Also: JWY (1), CDH (1), ITG (1), CIC (1), JFY (1), CEO (1).

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.

  • K946201Stand, InfusionMedical Specialties, Inc. · 19951cites it

What has FDA decided for it lately?

  • K946201Stand, InfusionMedical Specialties, Inc. · 1995
  • K931947CheckpointMedical Specialties, Inc. · 1993
  • K926095Refractrol-SPMedical Specialties, Inc. · 1993
  • K924926Msi-HCTMedical Specialties, Inc. · 1993
  • K896566Modified Fox Extra Gram Negative and PositiveMedical Specialties, Inc. · 1990
  • K883851Msi-Cal 8Medical Specialties, Inc. · 1988
  • K883850Msi-Cal 16Medical Specialties, Inc. · 1988
  • K883703Msi-Cal 7Medical Specialties, Inc. · 1988

All 40 as Medical Specialties, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K853776RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the…Jan 25, 2021Class II