Chrysalis Intelligence · Sponsors · CIVCO Medical Instruments Co., Inc.

CIVCO Medical Instruments Co., Inc.

Kalona, IA, US · 4 510(k) clearances · 13 recalls

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Total clearances
4
2021-09-13 → 2026-09-24
Last 12 months
1
Product codes
1
Most recent
2026-09-24
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
ITX Transducer, Ultrasonic, Diagnostic Class II Radiology 4 2026-09-24
Safety

Recalls (13)

Class I (serious)
0
Risk of injury / death
Total recalls
13
Currently ongoing
9
Most recent
2026-03-02
DateSeverityStatusRecall # ProductCodeReason
2026-03-02 Class II Ongoing Z-1738-2026 eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159 — There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be inc…
2026-03-02 Class II Ongoing Z-1737-2026 eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158 — There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be inc…
2026-03-02 Class II Ongoing Z-1736-2026 eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157 — There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be inc…
2026-03-02 Class II Ongoing Z-1735-2026 eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156 — There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be inc…
2026-03-02 Class II Ongoing Z-1734-2026 eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152 — There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be inc…
2026-03-02 Class II Ongoing Z-1733-2026 eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151 — There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be inc…
2026-03-02 Class II Ongoing Z-1732-2026 eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150 — There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be inc…
2026-03-02 Class II Ongoing Z-1731-2026 eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149 — There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be inc…
2025-05-01 Class II Ongoing Z-1892-2025 BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagno… — During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cov…
2021-10-08 Class II Terminated Z-0398-2022 VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX — There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
2021-10-08 Class II Terminated Z-0397-2022 VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX — There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
2021-10-08 Class II Terminated Z-0396-2022 VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX — There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
2021-10-08 Class II Terminated Z-0395-2022 VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX — There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2026-09-24 K260114 Align® Cover and Pad Guidance Tool ITX Class II Radiology
2023-11-14 K231783 VitroPRO ITX Class II Radiology
2022-11-22 K222052 VitroPRO ITX Class II Radiology
2021-09-13 K211270 CIV-Clear cover ITX Class II Radiology
Data source: openFDA · Generated 2026-10-06 10:35 · Last ingest 2026-10-06T14:35:17.195499 · Pipeline: Chrysalis Intelligence