510(k) · Cleared
Recalled · 2009Tao Brush I.U.M.C. Endometrial Sampler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Urological, Inc. · HFE Brush, Endometrial
Cleared on Nov 7, 2008 as substantially equivalent to K941298 (Cook Ob/Gyn, 1995) and 1 other predicate after a 108-day review. Its family tree reaches back 1 generation to 1988. 4 later devices descend from it. It has been recalled once.
- Decided
- Nov 7, 2008
- Review
- 108 days
- Class
- Class II
- Product code
- HFE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K881456 (1988). 2 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK881456 Pipelle DE Cornier Endometrial Suction CuretteLaboratoire Ccd C/O Washington Regulatory Services · 1988
- This deviceK082066 Tao Brush I.U.M.C. Endometrial SamplerCook Urological, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK170603 Tao Brush I.U.M.C. Endometrial SamplerCook Incorporated · 2017
- Descendant · 2 generations on · 0 of its ownK240595 Utepreva Endometrial Sampler (UP01)Utepreva, LLC · 2024
- Descendant · cites it directly · 0 of its ownK133144 Sonosure Sonohysterography & Endometrial Sampling DeviceCrossbay Medical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK112763 Matrixbrush Endometrial SamplerPost Oak Innovations, Inc. · 2012
Most influential descendants
Showing 4 of 4 · See all- K170603Tao Brush I.U.M.C. Endometrial SamplerCook Incorporated · 2017 · cites it directly1descendant
- K240595Utepreva Endometrial Sampler (UP01)Utepreva, LLC · 2024 · 2 generations on0descendants
- K133144Sonosure Sonohysterography & Endometrial Sampling DeviceCrossbay Medical, Inc. · 2014 · cites it directly0descendants
- K112763Matrixbrush Endometrial SamplerPost Oak Innovations, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881456 | Pipelle DE Cornier Endometrial Suction Curette | Laboratoire Ccd C/O Washington Regulatory Services | 1988 | — |
| 0 (this device) | K082066 | Tao Brush I.U.M.C. Endometrial Sampler | Cook Urological, Inc. | 2008 | — |
| +1 | K170603 | Tao Brush I.U.M.C. Endometrial Sampler | Cook Incorporated | 2017 | — |
| +2 | K240595 | Utepreva Endometrial Sampler (UP01) | Utepreva, LLC | 2024 | — |
| +1 | K133144 | Sonosure Sonohysterography & Endometrial Sampling Device | Crossbay Medical, Inc. | 2014 | — |
| +1 | K112763 | Matrixbrush Endometrial Sampler | Post Oak Innovations, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 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.
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? (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 |
|---|---|---|---|
| * | K941298 | Iumc Endometrial SamplerSummary page 1…Class II,HFE Predicate Devices: The Tao Brush TM I.U.M.C. Endometrial Sampler is identical to the Tao Brush T M I.U.M.C. Endometrial Sampler (version 1,K941298) indesign, materials of construction, and cytological sampling. The Tao Brush T M I.U.M.C. Endometrial Sampler is similar to the… | 1995 |
| * | K881456 | Pipelle DE Cornier Endometrial Suction CuretteSummary page 1…1,K941298) indesign, materials of construction, and cytological sampling. The Tao Brush T M I.U.M.C. Endometrial Sampler is similar to the Pipelle TM by CooperSurgical (K881456), inregards to histological sampling. Device Description: The Tao Brush TM I.U.M.C. Endometrial Sampler isa brush assembly fitt… | 1988 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K170603 (Cook Incorporated, 2017) has gone furthest, with 1 descendant 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. 2008, 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?
Used to obtain endometrial cytological and histological samples.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082066: Tao Brush I.U.M.C. 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/K082066
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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