510(k) · Cleared
ClearedAlien RX Micro Cannula, Model 4530
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
Cleared on Apr 30, 2001 as substantially equivalent to K833417 (Microvasive, 1983) after a 27-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Apr 30, 2001
- Review
- 27 days
- Class
- Class II
- Product code
- ODD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K833417 (1983). No later device cites it as a predicate yet.
- Root · 1 generation backK833417 Endoscopic RetrogradeMicrovasive · 1983
- This deviceK010993 Alien RX Micro Cannula, Model 4530Boston Scientific Corp · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K833417 | Endoscopic Retrograde | Microvasive | 1983 | — |
| 0 (this device) | K010993 | Alien RX Micro Cannula, Model 4530 | Boston Scientific Corp | 2001 | — |
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 ODD? 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 ODD device
- #1 K250573 Single Use Cannula V…score 9.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | K833417 | Endoscopic RetrogradeSummary page 4…RISTICS: PERFORMANCE DATA: Cannula Endoscope and Accessories Classified Under 21 CFR Part 876, Section 1500. Classified as a Class II Device. Contour™ ERCP Cannula (K833417, ERCP Cannula) The proposed Alien™ RX Micro Cannula is a single lumen cannula. It is compatible with the Boston Scientific Micro… | 1983 |
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 ODD devicesODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ODD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODD
Too few ODD 510(k)s in any year since 2007 to give a median.
Recalls per year · ODD
No recall names ODD since 2007.
Adverse event reports per year · ODD
4in 2025
MAUDE reports naming product code ODD, 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 | 1 |
| 2008 | 0 | — | 0 | 9 |
| 2009 | 0 | — | 0 | 26 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 13 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 1 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 1 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Alien™ RX Micro Cannula is indicated for use to cannulate and
inject contrast media into the biliary and pancreatic ductal systems.
Contrast medium is injected through the cannula and fluoroscopy or x-ray is performed to obtain a cholangiogram.
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/K010993 · printed Nov 3, 2026
Cite this page
510(k) Report. “K010993: Alien RX Micro Cannula, Model 4530.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K010993
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026