Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CIVCO Medical Instruments Co., Inc. — Predicate Candidate Screening
29 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
115 daysmedian FDA review time
172 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231783 | VitroPRO | CIVCO Medical Instruments Co., Inc. | 2023-11-14 | 151 | 0 |
| K222052 | VitroPRO | CIVCO Medical Instruments Co., Inc. | 2022-11-22 | 133 | 0 |
| K211270 | CIV-Clear cover | CIVCO Medical Instruments Co., Inc. | 2021-09-13 | 139 | 0 |
| K163313 | ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endova | CIVCO Medical Instruments Co., Inc. | 2017-06-09 | 198 | 0 |
| K160806 | Verza Guidance System | CIVCO Medical Instruments Co., Inc. | 2016-08-05 | 134 | 0 |
| K131161 | EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEP | CIVCO Medical Instruments Co., Inc. | 2013-09-17 | 146 | 0 |
| K131528 | NON-PYROGENIC ULTRASOUND TRANSDUCER COVER | CIVCO Medical Instruments Co., Inc. | 2013-06-11 | 14 | 0 |
| K080072 | MRI PATIENT POSITIONING DEVICES | CIVCO Medical Instruments Co., Inc. | 2008-06-04 | 145 | 0 |
| K013721 | SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER | CIVCO Medical Instruments Co., Inc. | 2001-12-28 | 49 | 3 |
| K002546 | CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE | CIVCO Medical Instruments Co., Inc. | 2000-10-31 | 75 | 0 |
| K992152 | GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STAND | CIVCO Medical Instruments Co., Inc. | 1999-08-17 | 53 | 0 |
| K991236 | GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX | CIVCO Medical Instruments Co., Inc. | 1999-06-02 | 51 | 0 |
| K970514 | DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NE | CIVCO Medical Instruments Co., Inc. | 1997-06-20 | 129 | 1 |
| K970513 | GENERAL PURPOSE TRANDUCER COVER | CIVCO Medical Instruments Co., Inc. | 1997-06-20 | 129 | 0 |
| K970515 | GENERAL PURPOSE LATEX TRANSDUCER COVERS | CIVCO Medical Instruments Co., Inc. | 1997-06-20 | 129 | 0 |
| K943393 | CIVCO PROBE BOOT/CORD COVER | CIVCO Medical Instruments Co., Inc. | 1995-02-02 | 203 | 0 |
| K900016 | TRANS/R - FP(3) | CIVCO Medical Instruments Co., Inc. | 1990-06-11 | 160 | 0 |
| K895614 | CIVCO LATEX ULTRASOUND SHEATHS | CIVCO Medical Instruments Co., Inc. | 1989-12-14 | 86 | 0 |
| K882383 | MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES | CIVCO Medical Instruments Co., Inc. | 1988-11-28 | 172 | 0 |
| K875128 | TRANS/R NEEDLE GUIDE | CIVCO Medical Instruments Co., Inc. | 1988-04-15 | 122 | 0 |
| K875240 | TRANS/V NEEDLE GUIDE | CIVCO Medical Instruments Co., Inc. | 1988-04-15 | 115 | 0 |
| K875236 | TRANS/P NEEDLE GUIDE | CIVCO Medical Instruments Co., Inc. | 1988-04-15 | 115 | 0 |
| K875241 | CIVCO SEED IMPLANT NEEDLE GUIDE | CIVCO Medical Instruments Co., Inc. | 1988-04-14 | 114 | 0 |
| K871413 | CIVCO STEPPER | CIVCO Medical Instruments Co., Inc. | 1987-07-14 | 97 | 0 |
| K862481 | CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE | CIVCO Medical Instruments Co., Inc. | 1986-07-23 | 23 | 0 |
| K844472 | CIVCO SCAN DRAPE | CIVCO Medical Instruments Co., Inc. | 1985-01-23 | 65 | 0 |
| K843573 | CIVCO-SUPER SCAN/BIOPSY GUIDE | CIVCO Medical Instruments Co., Inc. | 1984-12-13 | 93 | 0 |
| K841332 | CIVCO/SUPER SCAN | CIVCO Medical Instruments Co., Inc. | 1984-05-09 | 37 | 0 |
| K820269 | RNG SERIES ULTRASOUND NEEDLE/CATH. GDS | CIVCO Medical Instruments Co., Inc. | 1982-03-23 | 49 | 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