510(k) · Cleared
ClearedUtepreva Endometrial Sampler (UP01)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Utepreva, LLC · HFE Brush, Endometrial
Cleared on Aug 14, 2024 as substantially equivalent to K170603 (Cook Incorporated, 2017) after a 163-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Aug 14, 2024
- Review
- 163 days
- Class
- Class II
- Product code
- HFE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K881456 (1988). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK881456 Pipelle DE Cornier Endometrial Suction CuretteLaboratoire Ccd C/O Washington Regulatory Services · 1988
- 2 generations backK082066 Tao Brush I.U.M.C. Endometrial SamplerCook Urological, Inc. · 2008 · Recalled
- 1 generation backK170603 Tao Brush I.U.M.C. Endometrial SamplerCook Incorporated · 2017
- This deviceK240595 Utepreva Endometrial Sampler (UP01)Utepreva, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K881456 | Pipelle DE Cornier Endometrial Suction Curette | Laboratoire Ccd C/O Washington Regulatory Services | 1988 | — |
| −2 | K082066 | Tao Brush I.U.M.C. Endometrial Sampler | Cook Urological, Inc. | 2008 | 1 |
| −1 | K170603 | Tao Brush I.U.M.C. Endometrial Sampler | Cook Incorporated | 2017 | — |
| 0 (this device) | K240595 | Utepreva Endometrial Sampler (UP01) | Utepreva, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 HFE? 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? (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 |
|---|---|---|---|
| * | K170603 | Tao Brush I.U.M.C. Endometrial SamplerSummary page 4…ometrial brush Classification Name: Brush, Endometrial Regulation Number: 21 CFR 884.1100 Regulatory Class: Class II Product Code: HFE III. PREDICATE DEVICE K170603, Tao BrushTM I.U.M.C Endometrial The predicate device identified above has not been subject to design-related recalls. IV. DE… | 2017 |
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 36 years and passes through 4 companies; a new generation was cleared every 8.5 years on median.
- 2 of the 4 ancestors have a recall of any class.
How does its category compare?
All HFE devicesHFE Brush, Endometrial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · HFE
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HFE
Too few HFE 510(k)s in any year since 2007 to give a median.
Recalls per year · HFE
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HFE
1in 2016
MAUDE reports naming product code HFE, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Utepreva Endometrial Sampler (UP01) is used to obtain endometrial cytological and histological samples.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240595 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240595: Utepreva Endometrial Sampler (UP01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240595
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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