# K970513: General Purpose Tranducer Cover

- Pathway: 510(k) (Traditional)
- Applicant: CIVCO Medical Instruments Co., Inc.
- Decided: Jun 20, 1997 after 129 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: 1 generation back to K844472 (1985). 1 ancestor in all.
69 later devices descend from it; 6 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844472: Civco Scan Drape, CIVCO Medical Instruments Co., Inc. (1985) Summary page 1.

## Most influential descendants
- K092619: Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal Tracker (2009), 61 descendants of its own
- K141459: Aplio 500/400/300 Diagnostic Ultrasound System, V5.0 (2014), 39 descendants of its own
- K151451: Aplio 500/400/300 Diagnostic Ultrasound System V6.0 (2015), 34 descendants of its own
- K161843: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 (2016), 23 descendants of its own
- K163702: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 (2017), 22 descendants of its own

## Indications for use
Protective cover or sheath placed over diagnostic 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 diagnostic 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 Poly Ultrasound Transducer Covers are furnished sterile & non-sterile; single use patient / procedure, disposable.

Source page: https://510kreport.com/device/K970513
Methodology: https://510kreport.com/methodology