510(k) Report

FDA applicant

Utah Medical Products, Inc.

Midvale, UT38 decisions1979–20151 recall

FDA records 38 decisions for Utah Medical Products, Inc. (Midvale, UT) from 1979 to 2015: 38 510(k) clearances. Most are in product codes HGI (Electrocautery, Gynecologic (And Accessories)) and KPI (Stimulator, Electrical, Non-Implantable, For…). Its devices cite 18 predicates, 7 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

1in 2015

2007: 12011: 12013: 12015: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2008

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

Class I Class II/III not classified

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

Planning a device like Utah Medical Products, 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?

  • HGIElectrocautery, Gynecologic (And Accessories)4decisions
  • KPIStimulator, Electrical, Non-Implantable, For Incontinence4decisions
  • DRSTransducer, Blood-Pressure, Extravascular3decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories3decisions
  • HFNTransducer, Pressure, Intrauterine2decisions
  • KXOMonitor, Pressure, Intrauterine2decisions

Also: DTL (2), LKF (2), NBH (1), CBT (1), PFJ (1), HGP (1).

Whose devices does it build on?

Its devices cite 18 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 24 times; 7 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.

  • K960496Liberty Lite PFS SystemUtah Medical Products, Inc. · 19966cite it
  • K841788Utah Disposable Pressure TransducerUtah Medical Products, Inc. · 19854cite it
  • K960255Ceramic Blade ElectrodeUtah Medical Products, Inc. · 19964cite it
  • K842352Pressure Monitoring KitUtah Medical Products, Inc. · 19852cite it
  • K955093Aspiration/Coagulation Electrode Ace-311 & Ace-511Utah Medical Products, Inc. · 19961cites it
  • K905263Utah EssuUtah Medical Products, Inc. · 19911cites it

What has FDA decided for it lately?

  • K143424Utah CVX-RipeUtah Medical Products, Inc. · 2015
  • K123310Finesse 3RD Generation (Models Finesse+ and Finesseii+)Utah Medical Products, Inc. · 2013
  • K101535BT-CathUtah Medical Products, Inc. · 2011
  • K063611Saline/ Contrast Media Infusion CatheterUtah Medical Products, Inc. · 2007
  • K001874Peripherally Inserted Central CatheterUtah Medical Products, Inc. · 2000
  • K000974Fowler Endocurette, Model Cur-XXXUtah Medical Products, Inc. · 2000
  • K965245TBDUtah Medical Products, Inc. · 1997
  • K970077Liberty Plus System (PFS-300)/Vaginal Probe, Liberty Plus (PFS-044)Utah Medical Products, Inc. · 1997

All 38 as Utah Medical Products, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K905563Intran Plus, Disposable Intrauterine Pressure Catheter System, Part numbers IUP-400…Jun 16, 2008

Other applicant names beginning “Utah”

FDA records each applicant name separately; these may or may not be the same firm.

Utah Pioneer Medical, Inc. 2Utah Bioresearch, Inc. 1Utah Medical Products and Services 1