510(k) · Cleared
ClearedAnokryo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mk Conquest Intl., Inc. · FFP Dilator, Rectal
Cleared on Jun 6, 1997 as substantially equivalent to K862490 (J. & Jp., Inc., 1986) and 1 other predicate after a 199-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Jun 6, 1997
- Review
- 199 days
- Class
- Class I
- Product code
- FFP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K862490 (1986). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK862490 ANU-RXJ. & Jp., Inc. · 1986
- This deviceK964634 AnokryoMk Conquest Intl., Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862490 | ANU-RX | J. & Jp., Inc. | 1986 | — |
| 0 (this device) | K964634 | Anokryo | Mk Conquest Intl., Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FFP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K862490 | ANU-RXSummary page 1…y Name: Anokryo Common Name: Rectal Dilator Regulatory Class: Class| Product Code: 78FFP PREDICATE DEVICES Commercially available rectal dilators such as the Anurex (K862490) and the Inamed Rhemo-D (K894618). DEVICE DESCRIPTION The Anokryo Dilator consists of a narrow tapered shaft approximately 2.75… | 1986 |
| * | K894618 | Inamed Rhemo-D (TM) DilatorSummary page 1…al Dilator Regulatory Class: Class| Product Code: 78FFP PREDICATE DEVICES Commercially available rectal dilators such as the Anurex (K862490) and the Inamed Rhemo-D (K894618). DEVICE DESCRIPTION The Anokryo Dilator consists of a narrow tapered shaft approximately 2.75 inch long and 0.5 inch wide The… | 1990 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All FFP devicesFFP Dilator, Rectal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FFP
FDA has decided no FFP device since 2007.
Median 510(k) review, days · FFP
Too few FFP 510(k)s in any year since 2007 to give a median.
Recalls per year · FFP
No recall names FFP since 2007.
Adverse event reports per year · FFP
1in 2018
MAUDE reports naming product code FFP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964634 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964634: Anokryo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964634
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026