# K983181: Cytoprep

- Pathway: 510(k) (Traditional)
- Applicant: Cytoprep Inc. Est.
- Decided: Nov 16, 1998 after 66 days
- Product code: HHI (System, Abortion, Vacuum)
- Device class: 2
- Regulation: 21 CFR 884.5070
- 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 K915844 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930955: Cervex-Brush, Rovers B.V. (1994) Summary page 1.
- K915844: Exact-Touch, Baal Assoc., Inc. (1994) Summary page 1.

## Indications for use
The device is used to sample the cervix of patients for the purpose of obtaining ecto-cervical, endo-cervical and T-zone sample cells. These sample cells are used for the “PAP” test. While the product is designed to be used in conjunction with liquid based cytology procedure (monolayer method), it can also be used in conjunction with the traditional “PAP” test procedure.

Source page: https://510kreport.com/device/K983181
Methodology: https://510kreport.com/methodology