# CIVCO Medical Instruments Co., Inc.

- Location (FDA's records): Kalona, IA
- FDA decisions: 31 (1982–2026): 31 510(k) clearances
- Names in FDA's records: CIVCO Medical Instruments Co., Inc. (30); Civco Medical Instruments (1)
- Product codes: ITX (16), IYO (7), KNW (1), FCY (1), KKX (1), GDM (1), DWO (1), DWZ (1), FZX (1), IYE (1)
- 510(k) review time since 2016: median 151 days, against 151 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 32 (12 its own); citations of its devices by later devices: 61 (12 its own)
- Recalls linked to its devices: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtec, Inc.: 4 (https://510kreport.com/company/medtec)
- B-K Medical Aps: 3 (https://510kreport.com/company/b-k-medical)
- Civco Medical Solutions: 2 (https://510kreport.com/company/civco-medical-solutions)
- Parker Laboratories, Inc.: 1 (https://510kreport.com/company/parker-laboratories)
- Cone Instruments, Inc.: 1 (https://510kreport.com/company/cone-instruments)
- B-K Medical A/S: 1 (https://510kreport.com/company/b-k-medical-a-s)
- Bruel & Kjaer: 1 (https://510kreport.com/company/bruel-kjaer)
- Bruel & Kjaer Industri A/S: 1 (https://510kreport.com/company/bruel-kjaer-industri-a-s)

## Firms that cite its devices most
- Protek Medical Products, Inc.: 6 (https://510kreport.com/company/protek-medical-products)
- Sheathing Technologies, Inc.: 3 (https://510kreport.com/company/sheathing-technologies)
- Koelis: 3 (https://510kreport.com/company/koelis)
- Amertek Medical, Inc.: 2 (https://510kreport.com/company/amertek-medical)
- Civco: 2 (https://510kreport.com/company/civco)
- Medtec, Inc.: 2 (https://510kreport.com/company/medtec)
- Nw Radiation Therapy Products: 2 (https://510kreport.com/company/nw-radiation-therapy-products)
- Clk Intl., Inc.: 2 (https://510kreport.com/company/clk-intl)

## Its most-cited devices
- K970513: General Purpose Tranducer Cover (1997), cited by 6
- K871413: Civco Stepper (1987), cited by 5
- K970514: Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle Instrument Guide (1997), cited by 4
- K895614: Civco Latex Ultrasound Sheaths (1989), cited by 4
- K882383: Maggi Series Ultra. Needle, Biopsy/Catheter Guides (1988), cited by 4
- K093713: Ultrasound General Purpose Guidance System (2010), cited by 4

## Recent decisions
- K260114: Align® Cover and Pad Guidance Tool (Sep 24, 2026)
- K231783: VitroPRO (Nov 14, 2023)
- K222052: VitroPRO (Nov 22, 2022)
- K211270: CIV-Clear cover (Sep 13, 2021)
- K163313: ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor (Jun 9, 2017)
- K160806: Verza Guidance System (Aug 5, 2016)
- K131161: EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper; Micro-Touch, Micro-Touch LP, Mulit-Purpose Workstation, (Sep 17, 2013)
- K131528: Non-Pyrogenic Ultrasound Transducer Cover (Jun 11, 2013)

Source page: https://510kreport.com/company/civco-medical-instruments