Utah Medical Products, Inc.: FDA filings under this applicant name
FDA lists 38 510(k) clearances under the applicant name “Utah Medical Products, Inc.” (first 1979, latest 2015), across 24 product codes in 7 review panels. Median 510(k) review time under this name: 140 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 90 |
| 2014 | 0 | — |
| 2015 | 1 | 270 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HGI | Electrocautery, Gynecologic (And Accessories) | 4 | 4 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 4 | 4 |
| DRS | Transducer, Blood-Pressure, Extravascular | 3 | 3 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 2 | 2 |
| HFN | Transducer, Pressure, Intrauterine | 2 | 2 |
| KXO | Monitor, Pressure, Intrauterine | 2 | 2 |
| LKF | Cannula, Manipulator/Injector, Uterine | 2 | 2 |
| BXN | Stimulator, Nerve, Battery-Powered | 1 | 1 |
| BXX | Calibrator, Pressure, Gas | 1 | 1 |
Plus 14 more product codes.
Review panels
- Obstetrics and Gynecology (16)
- Anesthesiology (5)
- Cardiovascular (5)
- Gastroenterology and Urology (4)
- General and Plastic Surgery (3)
- General Hospital (2)
- Orthopedic (2)
Most recent Utah Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K143424 | UTAH CVX-RIPE | PFJ | 2015-08-28 | 270 |
| K123310 | FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+) | GEI | 2013-01-23 | 90 |
| K101535 | BT-CATH | OQY | 2011-01-11 | 222 |
| K063611 | SALINE/ CONTRAST MEDIA INFUSION CATHETER | LKF | 2007-05-23 | 171 |
| K001874 | PERIPHERALLY INSERTED CENTRAL CATHETER | LJS | 2000-09-25 | 97 |
| K000974 | FOWLER ENDOCURETTE, MODEL CUR-XXX | HHK | 2000-05-23 | 57 |
| K965245 | TBD | HGI | 1997-07-03 | 184 |
| K970077 | LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044) | KPI | 1997-05-23 | 134 |
| K955663 | ABC IN-LINE BLOOD SAMPLING KIT | CBT | 1997-03-17 | 460 |
| K964526 | LIBERTY RECTAL PELVIC FLOOR EXERCISER | KPI | 1997-02-10 | 90 |
28 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2015-10-16.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
UTAH MEDICAL PRODUCTS INC (UTMD): EDGAR filings, CIK 706698. An SEC registrant with the same name, matched by name only.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Utah Medical Products, Inc. (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Utah Pioneer Medical, Inc. (2 510(k)s)
- Utah Bioresearch, Inc. (1 510(k)s)
- Utah Medical Products and Services (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Utah Medical Products, Inc.?
FDA lists 38 510(k) clearances under the applicant name “Utah Medical Products, Inc.” (first 1979, latest 2015), across 24 product codes in 7 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Utah Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Utah Medical Products, Inc. is 140 days.
Which FDA product codes appear under Utah Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are HGI (Electrocautery, Gynecologic (And Accessories), 4); KPI (Stimulator, Electrical, Non-Implantable, For Incontinence, 4); DRS (Transducer, Blood-Pressure, Extravascular, 3).
Next steps
- See all 38 Utah Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HGI, Utah Medical Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.