510(k) · Cleared
ClearedVision Biosystems Estrogen Receptor Clone 6F11 (ER 6F11)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vision Biosystems, Inc. · MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
Cleared on May 25, 2006 after a 115-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- May 25, 2006
- Review
- 115 days
- Class
- Class II
- Product code
- MYA
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK060227 Vision Biosystems Estrogen Receptor Clone 6F11 (ER 6F11)Vision Biosystems, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK122556 Vision Biosystems Estrogen Receptor Clone 6F11 (ER 6F11)Leica Biosystems Newcastle, Ltd. · 2014
Most influential descendants
Showing 1 of 1 · See all- K122556Vision Biosystems Estrogen Receptor Clone 6F11 (ER 6F11)Leica Biosystems Newcastle, Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060227 | Vision Biosystems Estrogen Receptor Clone 6F11 (ER 6F11) | Vision Biosystems, Inc. | 2006 | — |
| +1 | K122556 | Vision Biosystems Estrogen Receptor Clone 6F11 (ER 6F11) | Leica Biosystems Newcastle, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 MYA? 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 |
|---|---|---|---|
| * | — | Ventana Medical Systems Estrogen Receptor Clone 6F11 Named without a submission number | |
| * | — | DAKO Corporation Mouse Monoclonal Estrogen Receptor Clone 1D5 Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122556 | Vision Biosystems Estrogen Receptor Clone 6F11 (ER 6F11) | 2014 | 0 |
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?
- Of its descendants, K122556 (Leica Biosystems Newcastle, Ltd., 2014) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MYA devicesMYA Immunohistochemistry Antibody Assay, Estrogen Receptor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MYA
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · MYA
Too few MYA 510(k)s in any year since 2007 to give a median.
Recalls per year · MYA
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MYA
2in 2025
MAUDE reports naming product code MYA, 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 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 2 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Vision BioSystems Estrogen Receptor Clone 6F1 1 (ER 6F1 1) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify by light microscopy, estrogen receptor (ER) antigen in sections of formalin fixed, paraffin embedded tissue. Estrogen Receptor Clone 6F1 I specifically binds to the ER antigen located inthe nucleus of ER positive normal and neoplastic cells. ER 6Fl1 is indicated as an aid in the management, prognosis and prediction…
Read the full statement (137 words)
Vision BioSystems Estrogen Receptor Clone 6F1 1 (ER 6F1 1) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify by light microscopy, estrogen receptor (ER) antigen in sections of formalin fixed, paraffin embedded tissue. Estrogen Receptor Clone 6F1 I specifically binds to the ER antigen located inthe nucleus of ER positive normal and neoplastic cells. ER 6Fl1 is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
OriginrM antibodies are optimized for use with the Ventana® Medical Systems, NexES® and BenchMarkTM Immunohistochemistry Staining Systems in combination with Ventana® Detection Kits.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060227 · printed Nov 3, 2026
Cite this page
510(k) Report. “K060227: Vision Biosystems Estrogen Receptor Clone 6F11 (ER 6F11).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K060227
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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