# K260114: Align® Cover and Pad Guidance Tool

- Pathway: 510(k) (Traditional)
- Applicant: CIVCO Medical Instruments Co., Inc.
- Decided: Sep 24, 2026 after 253 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: 6 generations back to K850478 (1985). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190802: Envision ultrasound pad and cover, Civco Medical Solutions (2019) Summary page 5.
- K093713: Ultrasound General Purpose Guidance System, Civco Medical Instruments (2010) Summary page 6.

## Indications for use
The medical device is intended to provide a guide for interventional devices while also serving as a microbial barrier between the patient and the ultrasound transducer. • Abdominal - Diagnostic imaging and minimally invasive puncture procedures. • Small Parts - Diagnostic imaging and minimally invasive puncture procedures. • Regional Anesthesia - Diagnostic imaging and minimally invasive puncture procedures. • Vascular Access - Diagnostic imaging and minimally invasive puncture procedures.

Source page: https://510kreport.com/device/K260114
Methodology: https://510kreport.com/methodology