Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Utah Medical Products, Inc. · Predicate Candidate Screening
38 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
147 daysmedian FDA review time
299 days90th percentile
38clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K143424 | UTAH CVX-RIPE | Utah Medical Products, Inc. | 2015-08-28 | 270 | 0 |
| K123310 | FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+) | Utah Medical Products, Inc. | 2013-01-23 | 90 | 0 |
| K101535 | BT-CATH | Utah Medical Products, Inc. | 2011-01-11 | 222 | 0 |
| K063611 | SALINE/ CONTRAST MEDIA INFUSION CATHETER | Utah Medical Products, Inc. | 2007-05-23 | 171 | 0 |
| K001874 | PERIPHERALLY INSERTED CENTRAL CATHETER | Utah Medical Products, Inc. | 2000-09-25 | 97 | 0 |
| K000974 | FOWLER ENDOCURETTE, MODEL CUR-XXX | Utah Medical Products, Inc. | 2000-05-23 | 57 | 0 |
| K965245 | TBD | Utah Medical Products, Inc. | 1997-07-03 | 184 | 0 |
| K970077 | LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS | Utah Medical Products, Inc. | 1997-05-23 | 134 | 0 |
| K955663 | ABC IN-LINE BLOOD SAMPLING KIT | Utah Medical Products, Inc. | 1997-03-17 | 460 | 0 |
| K964526 | LIBERTY RECTAL PELVIC FLOOR EXERCISER | Utah Medical Products, Inc. | 1997-02-10 | 90 | 0 |
| K961424 | INTRAN 500 | Utah Medical Products, Inc. | 1996-07-10 | 89 | 1 |
| K960496 | LIBERTY LITE PFS SYSTEM | Utah Medical Products, Inc. | 1996-06-27 | 147 | 0 |
| K955093 | ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511 | Utah Medical Products, Inc. | 1996-04-29 | 174 | 0 |
| K960255 | CERAMIC BLADE ELECTRODE | Utah Medical Products, Inc. | 1996-03-27 | 70 | 0 |
| K955443 | INTRAN PLUS | Utah Medical Products, Inc. | 1996-02-20 | 84 | 1 |
| K954619 | CORDGUARD II | Utah Medical Products, Inc. | 1995-12-21 | 77 | 0 |
| K952981 | FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC | Utah Medical Products, Inc. | 1995-08-28 | 61 | 0 |
| K943448 | LUMIN | Utah Medical Products, Inc. | 1995-04-11 | 267 | 0 |
| K951032 | FINESS I (DERMATOLOGIC APPLICATION) | Utah Medical Products, Inc. | 1995-04-06 | 31 | 0 |
| K943250 | LIBERTY | Utah Medical Products, Inc. | 1995-02-09 | 218 | 0 |
| K941251 | FINESSE IEC/601 | Utah Medical Products, Inc. | 1994-12-12 | 272 | 0 |
| K920152 | BUBBLE TOCO | Utah Medical Products, Inc. | 1993-05-26 | 499 | 0 |
| K905263 | UTAH ESSU | Utah Medical Products, Inc. | 1991-09-18 | 299 | 0 |
| K905092 | NEUROMUSCULAR TRANSMISSION MONITOR | Utah Medical Products, Inc. | 1991-06-25 | 223 | 0 |
| K905563 | INTRAN PLUS | Utah Medical Products, Inc. | 1991-06-19 | 189 | 1 |
| K905830 | COMBO FETAL SCALP ELECTRODE/LEGPLATE | Utah Medical Products, Inc. | 1991-03-29 | 88 | 0 |
| K901237 | GLOVE LEAK DETECTOR | Utah Medical Products, Inc. | 1990-08-21 | 159 | 0 |
| K864090 | SHELF LIFE CHANGE OF STERILE DEVICES | Utah Medical Products, Inc. | 1987-03-20 | 178 | 0 |
| K862873 | IUC - INTRAUTERINE CATHETER | Utah Medical Products, Inc. | 1987-02-26 | 211 | 0 |
| K861783 | DISPOSABLE STOPCOCK | Utah Medical Products, Inc. | 1986-07-17 | 70 | 0 |
| K854960 | DISPOSABLE MANIFOLD | Utah Medical Products, Inc. | 1986-02-10 | 61 | 0 |
| K850029 | UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL | Utah Medical Products, Inc. | 1985-04-29 | 115 | 0 |
| K841788 | UTAH DISPOSABLE PRESSURE TRANSDUCER | Utah Medical Products, Inc. | 1985-03-25 | 329 | 0 |
| K842352 | PRESSURE MONITORING KIT | Utah Medical Products, Inc. | 1985-03-25 | 283 | 0 |
| K822560 | IRRIGATION SET | Utah Medical Products, Inc. | 1982-12-03 | 101 | 0 |
| K821672 | PROFLEX | Utah Medical Products, Inc. | 1982-07-22 | 43 | 0 |
| K792144 | DISPOSA-HOOD | Utah Medical Products, Inc. | 1979-12-05 | 43 | 0 |
| K791177 | DISPIRO | Utah Medical Products, Inc. | 1979-08-10 | 46 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda