510(k) Report

FDA applicant

Wescor, Inc.

Logan, UT13 decisions1983–20132 recalls

FDA records 13 decisions for Wescor, Inc. (Logan, UT) from 1983 to 2013: 13 510(k) clearances. Most are in product codes KTB (Device, Iontophoresis, Specific Uses) and KPA (Slide Stainer, Automated). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are 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 Wescor, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Wescor, 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?

  • KTBDevice, Iontophoresis, Specific Uses3decisions
  • KPASlide Stainer, Automated2decisions
  • JJMOsmometer For Clinical Use2decisions
  • JTSStains, Microbiologic1decision
  • JFSCoulometric, Chloride1decision
  • CGZElectrode, Ion-Specific, Chloride1decision

Also: GJL (1), IAF (1), FLL (1).

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K853973Wescor Model 3700 Webster Sweat InducerWescor, Inc. · 19851cites it

What has FDA decided for it lately?

  • K121823Clinical Chloride Analyzer, Chloride Test System, Sweat Chloride Analyzer, Chloridometer, Chloride CoulometricWescor, Inc. · 2013
  • K010031Nanoduct Neonatal Sweat Analysis SystemWescor, Inc. · 2001
  • K863395Wescor Sweat.Chek Sweat Conductivity AnalyzerWescor, Inc. · 1988
  • K881592Wescor Model 7300 Aerospray Gram StainerWescor, Inc. · 1988
  • K881512Wescor Gram Stain Pack for Model 7300 AerosprayWescor, Inc. · 1988
  • K880544Wescor Stain Concentrate for Model 7100 AerosprayWescor, Inc. · 1988
  • K853973Wescor Model 3700 Webster Sweat InducerWescor, Inc. · 1985
  • K834214Wescor 5500 Vapor Pressure OsmometerWescor, Inc. · 1984

All 13 as Wescor, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K834208Osmocoll, COP Control Reference, SS-038, Contents: 6 unit packages of 1 mL vials (3 each…Dec 26, 2007
  • K834208Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials…Dec 26, 2007