# K013721: Synthetic Polysioprene Ultrasound Transducer Cover

- Pathway: 510(k) (Traditional)
- Applicant: CIVCO Medical Instruments Co., Inc.
- Decided: Dec 28, 2001 after 49 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K895614 (1989). 3 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991236: General Purpose Neoflex Transducer Cover, Edocavity Neoflex Transducer Cover, Surgi-Tip Intraoperative Transducer Cover,, CIVCO Medical Instruments Co., Inc. (1999) Summary page 2.

## Most influential descendants
- 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
- K120800: Nvision Vle Imaging System (2013), 6 descendants of its own
- K143678: NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory (2015), 5 descendants of its own
- K153479: NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System (2016), 2 descendants of its own

## Recalls of this device
- Feb 26, 2015 · Class II · Z-1400-2015: Leaks were detected in the recalled lot which may compromise the sterility of the product.
- Jan 21, 2011 · Not classified · Z-1607-2011: Non-sterile transducer covers were incorrectly labeled as sterile and contained incorrect temperature storage information.
- Jul 20, 2010 · Not classified · Z-2242-2010: Polyethylene material did not have proper treatment applied during manufacturing. Untreated polyethylene material does not maintain a secure seal with the adhesive tape used to secure the tip to the c

## Indications for use
Protective cover or sheath is placed over an ultrasound transducer / probe / scanhead instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, and intra-operative ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer (both sterile and non-sterile covers). The cover also provides a means for maintenance of a sterile field (sterile covers only). CIVCO Synthetic Polyisoprene Ultrasound Transducer Covers are furnished sterile and non-sterile, single use patient / procedure, disposable.

Source page: https://510kreport.com/device/K013721
Methodology: https://510kreport.com/methodology