510(k) · Cleared
ClearedBard and Bta Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bard Diagnostic Sciences,Inc. · MMW System, Test, Tumor Marker, Monitoring, Bladder
Cleared on Apr 16, 1997 after a 197-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 3 later devices descend from it.
- Decided
- Apr 16, 1997
- Review
- 197 days
- Class
- Class II
- Product code
- MMW
- Recalls
- None
- Predicates
- 1
3 later devices descend from it, 3 citing it directly.
- This deviceK964151 Bard and Bta TestBard Diagnostic Sciences,Inc. · 1997
- Descendant · cites it directly · 0 of its ownK994356 ImmunocytDiagnocure, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK974845 Bta Stat Test Prescription Home UseBard Diagnostic Sciences,Inc. · 1998
- Descendant · cites it directly · 0 of its ownK971402 Bard Bta Trak TestBard Diagnostic Sciences,Inc. · 1998
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964151 | Bard and Bta Test | Bard Diagnostic Sciences,Inc. | 1997 | — |
| +1 | K994356 | Immunocyt | Diagnocure, Inc. | 2000 | — |
| +1 | K974845 | Bta Stat Test Prescription Home Use | Bard Diagnostic Sciences,Inc. | 1998 | — |
| +1 | K971402 | Bard Bta Trak Test | Bard Diagnostic Sciences,Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2000 | 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 MMW? 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 MMW device
- #1 K203245 Bladder EpiCheck DNA extraction kit…score 5.3 · 1 generation · no Class I recall
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | P940018 | Bard® BTA® Test Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…aul Freiberg (206) 814-1520 (206) 814-1521 September 11, 1996 Bard® BTA stat™ Test BTA stat™Test Tumor Associated Antigen Immunological Test System Bard® BTA® Test P940018 - Reclassified to Class II Bard Diagnostic Sciences, Inc., claims substantial equivalence to the above mentioned test. === Pag… |
What descends from it? (3)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K994356 (Diagnocure, Inc., 2000) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MMW devicesMMW System, Test, Tumor Marker, Monitoring, Bladder: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MMW
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MMW
Too few MMW 510(k)s in any year since 2007 to give a median.
Recalls per year · MMW
No recall names MMW since 2007.
Adverse event reports per year · MMW
1in 2013
MAUDE reports naming product code MMW, 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BTA stat test is a qualitative test indicated for use as an aid in the management of bladder cancer patients in conjunction with cystoscopy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964151 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964151: Bard and Bta Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964151
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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