510(k) · Cleared
Recalled · 2009Iumc Endometrial Sampler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Ob/Gyn · HFE Brush, Endometrial
Cleared on Feb 13, 1995 after a 333-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled once.
- Decided
- Feb 13, 1995
- Review
- 333 days
- Class
- Class II
- Product code
- HFE
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK941298 Iumc Endometrial SamplerCook Ob/Gyn · 1995
- Descendant · cites it directly · 4 of its ownK082066 Tao Brush I.U.M.C. Endometrial SamplerCook Urological, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 1 of its ownK170603 Tao Brush I.U.M.C. Endometrial SamplerCook Incorporated · 2017
- Descendant · 3 generations on · 0 of its ownK240595 Utepreva Endometrial Sampler (UP01)Utepreva, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK133144 Sonosure Sonohysterography & Endometrial Sampling DeviceCrossbay Medical, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK112763 Matrixbrush Endometrial SamplerPost Oak Innovations, Inc. · 2012
Most influential descendants
Showing 5 of 5 · See all- K082066Tao Brush I.U.M.C. Endometrial SamplerCook Urological, Inc. · 2008 · cites it directly4descendants
- K170603Tao Brush I.U.M.C. Endometrial SamplerCook Incorporated · 2017 · 2 generations on1descendant
- K240595Utepreva Endometrial Sampler (UP01)Utepreva, LLC · 2024 · 3 generations on0descendants
- K133144Sonosure Sonohysterography & Endometrial Sampling DeviceCrossbay Medical, Inc. · 2014 · 2 generations on0descendants
- K112763Matrixbrush Endometrial SamplerPost Oak Innovations, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941298 | Iumc Endometrial Sampler | Cook Ob/Gyn | 1995 | — |
| +1 | K082066 | Tao Brush I.U.M.C. Endometrial Sampler | Cook Urological, Inc. | 2008 | 1 |
| +2 | K170603 | Tao Brush I.U.M.C. Endometrial Sampler | Cook Incorporated | 2017 | — |
| +3 | K240595 | Utepreva Endometrial Sampler (UP01) | Utepreva, LLC | 2024 | — |
| +2 | K133144 | Sonosure Sonohysterography & Endometrial Sampling Device | Crossbay Medical, Inc. | 2014 | — |
| +2 | K112763 | Matrixbrush Endometrial Sampler | Post Oak Innovations, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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.
Top candidate predicates for a new HFE device
- #1 K240595 Utepreva Endometrial Sampler (UP01)score 8.4 · 3 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082066 | Tao Brush I.U.M.C. Endometrial Sampler | 2008 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 2, 2009 | Not classified | Z-1416-2009 | Process control | There is an ink on the brush which has not been tested for use with the Tao Brush. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K082066 (Cook Urological, Inc., 2008) has gone furthest, with 4 descendants of its own.
How does its category compare?
All HFE devicesHFE Brush, Endometrial: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K941298 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941298: Iumc Endometrial Sampler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941298
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026