510(k) · Cleared
ClearedHemorpex System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Angiologica B. M. Srl · FER Anoscope And Accessories
Cleared on May 29, 2009 as substantially equivalent to K070913 (Sapimed S.P.A., 2007) after a 99-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- May 29, 2009
- Review
- 99 days
- Class
- Class II
- Product code
- FER
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K993738 (2000). 5 ancestors in all, the oldest K810227 (1981). No later device cites it as a predicate yet.
- Root · 3 generations backK993738 Dispos-a-ScopeDispos-A-Scope · 2000
- 2 generations backK020702 O'regan Disposable AnoscopeCanadian Theatre Products, Ltd. · 2002
- 1 generation backK070913 Self-Light Disposable AnoscopeSapimed S.P.A. · 2007 · Recalled
- This deviceK090432 Hemorpex SystemAngiologica B. M. Srl · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K993738 | Dispos-a-Scope | Dispos-A-Scope | 2000 | — |
| −2 | K020702 | O'regan Disposable Anoscope | Canadian Theatre Products, Ltd. | 2002 | — |
| −1 | K070913 | Self-Light Disposable Anoscope | Sapimed S.P.A. | 2007 | 1 |
| 0 (this device) | K090432 | Hemorpex System | Angiologica B. M. Srl | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1996 | 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 FER? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FER device
- #1 K250645 SleeveLUX 24 Anoscope/Proctoscope (P2001)…score 10.8 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K070913 | Self-Light Disposable AnoscopeSummary page 2…HEMORPEX SYSTEM (HPS) SAPIMED PRODUCT CODE FER FER K NUMBER K090432 K070913 COMMON NAME Disposable Anoscope Disposable Anoscope INTENDED USE The HEMORPEX SYSTEM (HPS) is Intended… | 2007 |
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?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 4 other devices also cite its predicate K070913.
How does its category compare?
All FER devicesFER Anoscope And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FER
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FER
Too few FER 510(k)s in any year since 2007 to give a median.
Recalls per year · FER
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FER
3in 2025
MAUDE reports naming product code FER, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 1 | 4 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 18 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The HEMORPEX SYSTEM (HPS) is intended for physician use to examine the anal sphincter and anus and to perform several diagnostic and therapeutic procedures, such as surgical treatment for hemorrhoidal disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090432 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090432: Hemorpex System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090432
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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