# K970893: Ultrasound Transducer Drape

- Pathway: 510(k) (Traditional)
- Applicant: Protek Medical Products, Inc.
- Decided: Oct 20, 1997 after 223 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K844472: Civco Scan Drape, CIVCO Medical Instruments Co., Inc. (1985). Our OCR of the scanned summary read K844472, FDA’s number for Civco Scan Drape (CIVCO Medical Instruments Co., Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Civeo’s legally marketed devices”. Kept off the family tree. Summary page 2.

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

Source page: https://510kreport.com/device/K970893
Methodology: https://510kreport.com/methodology