# K964634: Anokryo

- Pathway: 510(k) (Traditional)
- Applicant: Mk Conquest Intl., Inc.
- Decided: Jun 6, 1997 after 199 days
- Product code: FFP (Dilator, Rectal)
- Device class: 1
- Regulation: 21 CFR 876.5450
- 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 K862490 (1986). 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)
- K862490: ANU-RX, J. & Jp., Inc. (1986) Summary page 1.
- K894618: Inamed Rhemo-D (TM) Dilator, Inamed Development Co. (1990) Summary page 1.

## Indications for use
Dilation of the anal sphincter and canal for the relief of hemorrhoidal pain and itching, reduction of bleeding, and promotion of healing of inflamed hemorrhoidal tissues.

Source page: https://510kreport.com/device/K964634
Methodology: https://510kreport.com/methodology