# K970889: Ultrasound Transducer Drape

- Pathway: 510(k) (Traditional)
- Applicant: Protek Medical Products, Inc.
- Decided: Oct 20, 1997 after 223 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- 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.
13 later devices descend from it; 1 cites it directly.
0 of 15 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 2.

## Most influential descendants
- K042445: Site-Rite Needle Guide Kits and Probe Cover Kit (2004), 12 descendants of its own
- K120882: Site Rite Prevue Ultrasound System and Pinpoint Needle Guide (2012), 8 descendants of its own
- K152554: Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology (2015), 6 descendants of its own
- K182281: Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech (2018), 4 descendants of its own
- K211193: BD Prevue II Peripheral Vascular Vascular Access System (2021), 2 descendants of its own

## Indications for use
Drapes on Ultrasound Transducers used as protective coverings to isolate a site of surgical incisions from microbial and other contaminations.

Source page: https://510kreport.com/device/K970889
Methodology: https://510kreport.com/methodology