# K895614: Civco Latex Ultrasound Sheaths

- Pathway: 510(k) (Traditional)
- Applicant: CIVCO Medical Instruments Co., Inc.
- Decided: Dec 14, 1989 after 86 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
25 later devices descend from it; 4 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K970515: General Purpose Latex Transducer Covers (1997), 21 descendants of its own
- K991236: General Purpose Neoflex Transducer Cover, Edocavity Neoflex Transducer Cover, Surgi-Tip Intraoperative Transducer Cover, (1999), 16 descendants of its own
- K013721: Synthetic Polysioprene Ultrasound Transducer Cover (2001), 14 descendants of its own
- K041077: Imalux Oct Probe Guide (2004), 10 descendants of its own
- K112770: Nvision Vle Imaging System, Nvision Vle Catheter (2011), 9 descendants of its own

Source page: https://510kreport.com/device/K895614
Methodology: https://510kreport.com/methodology