CIVCO Medical Instruments Co., Inc.: FDA filings under this applicant name
FDA lists 30 510(k) clearances under the applicant name “CIVCO Medical Instruments Co., Inc.” (first 1982, latest 2023), across 10 product codes in 5 review panels. Median 510(k) review time under this name: 115 days. Since 2017 the median was 145 days, against 116 days for all cleared 510(k)s in the same product codes. 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 | 2 | 80 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 134 |
| 2017 | 1 | 198 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 139 |
| 2022 | 1 | 133 |
| 2023 | 1 | 151 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name CIVCO Medical Instruments Co., Inc. took a median 145 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | 15 | 15 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 7 | 7 |
| DWO | Needle, Biopsy, Cardiovascular | 1 | 1 |
| DWZ | Device, Biopsy, Endomyocardial | 1 | 1 |
| FCY | Bulb, Inflation, For Endoscope | 1 | 1 |
| FZX | Guide, Surgical, Instrument | 1 | 1 |
| GDM | Needle, Aspiration And Injection, Reusable | 1 | 1 |
| IYE | Accelerator, Linear, Medical | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
| KNW | Instrument, Biopsy | 1 | 1 |
Review panels
- Radiology (23)
- General and Plastic Surgery (4)
- Cardiovascular (1)
- Gastroenterology and Urology (1)
- General Hospital (1)
Most recent CIVCO Medical Instruments Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231783 | VitroPRO | ITX | 2023-11-14 | 151 |
| K222052 | VitroPRO | ITX | 2022-11-22 | 133 |
| K211270 | CIV-Clear cover | ITX | 2021-09-13 | 139 |
| K163313 | ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor | ITX | 2017-06-09 | 198 |
| K160806 | Verza Guidance System | ITX | 2016-08-05 | 134 |
| K131161 | EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION, | ITX | 2013-09-17 | 146 |
| K131528 | NON-PYROGENIC ULTRASOUND TRANSDUCER COVER | ITX | 2013-06-11 | 14 |
| K093713 | ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM | ITX | 2010-01-19 | 49 |
| K080072 | MRI PATIENT POSITIONING DEVICES | IYE | 2008-06-04 | 145 |
| K013721 | SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER | ITX | 2001-12-28 | 49 |
20 earlier clearances. See the full list in Caduvo.
Recalls
53 product recalls in 17 recall events; 13 initiated in the last five years. Most recent: 2026-03-02.
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.
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.
- Civco (2 510(k)s)
- Civco Medical Solutions (2 510(k)s)
- Civco Medical Instruments CO Inc Dba Civco Medical Solutions (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under CIVCO Medical Instruments Co., Inc.?
FDA lists 30 510(k) clearances under the applicant name “CIVCO Medical Instruments Co., Inc.” (first 1982, latest 2023), across 10 product codes in 5 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 CIVCO Medical Instruments Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name CIVCO Medical Instruments Co., Inc. is 115 days. Since 2017: 145 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under CIVCO Medical Instruments Co., Inc.?
The most frequent FDA product codes under this applicant name are ITX (Transducer, Ultrasonic, Diagnostic, 15); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 7); DWO (Needle, Biopsy, Cardiovascular, 1).
Next steps
- See all 30 CIVCO Medical Instruments Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code ITX, CIVCO Medical Instruments Co., 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.