# K222052: VitroPRO

- Pathway: 510(k) (Traditional)
- Applicant: CIVCO Medical Instruments Co., Inc.
- Decided: Nov 22, 2022 after 133 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K875128 (1988). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970514: Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle Instrument Guide, CIVCO Medical Instruments Co., Inc. (1997) Summary page 4.

## Most influential descendants
- K261170: BA-004CC (2026), 0 descendants of its own
- K231783: VitroPRO (2023), 0 descendants of its own

## Indications for use
This device provides physicians with a tool for performing needle/instrument guided procedures with the use of diagnostic ultrasound endocavity transducers. • Transvaginal - Diagnostic ultrasound needle / instrument guided procedures such as tissue biopsy, fluid aspiration, catheter placement, treatment, and oocyte retrieval. • Transrectal - Diagnostic ultrasound needle / instrument guided procedures such as tissue biopsy, fluid aspiration, catheter placement, treatment.

Source page: https://510kreport.com/device/K222052
Methodology: https://510kreport.com/methodology