510(k) · Cleared
ClearedUltra-CBX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcanica, Inc. · DWZ Device, Biopsy, Endomyocardial
Cleared on Nov 5, 1999 as substantially equivalent to K914567 (Cordis Corp., 1991) after a 191-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Nov 5, 1999
- Review
- 191 days
- Class
- Class II
- Product code
- DWZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K914567 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK914567 Cordis Bipal Biopsy ForcepsCordis Corp. · 1991
- This deviceK991486 Ultra-CBXMedcanica, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914567 | Cordis Bipal Biopsy Forceps | Cordis Corp. | 1991 | — |
| 0 (this device) | K991486 | Ultra-CBX | Medcanica, Inc. | 1999 | — |
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 DWZ? 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 DWZ device
- #1 K252722 Biopsy Forcepsscore 10.7 · 3 generations · 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K914567 | Cordis Bipal Biopsy ForcepsSummary page 1…Inc. Endomyocardial Biopsy Forceps (EMB) is substantially equivalent to the BiPal Biopsy Forceps manufactured and marketed by the Cordis Corporation pur- suant to 510(k) K914567. ’ General Description The EMB is sterile, single use, radiopaque, disposable device that is delivered non-toxic and non-pyroge… | 1991 |
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?
- Its one ancestor has no recall.
How does its category compare?
All DWZ devicesDWZ Device, Biopsy, Endomyocardial: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWZ
Too few DWZ 510(k)s in any year since 2007 to give a median.
Recalls per year · DWZ
No recall names DWZ since 2007.
Adverse event reports per year · DWZ
1in 2025
MAUDE reports naming product code DWZ, 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 | 1 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Endomyocardial Biopsy Forceps are designed for endomyocardial biopsies.
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/K991486 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991486: Ultra-CBX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991486
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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