510(k) · Cleared
ClearedEndolumina II Transillumination System 56FR E-5630, 50FR E-5030 and 40FR E-4020, Endolumina II Detachable Tips, 56FR, TA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioenterics Corp. · FDG Retractor, Fiberoptic
Cleared on Feb 11, 1997 after a 90-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Feb 11, 1997
- Review
- 90 days
- Class
- Class I
- Product code
- FDG
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK964561 Endolumina II Transillumination System 56FR E-5630, 50FR E-5030 and…Bioenterics Corp. · 1997
- Descendant · cites it directly · 2 of its ownK991323 Smith & Nephew Subcutaneous IlluminatorSmith & Nephew, Inc. · 1999
- Descendant · 2 generations on · 1 of its ownK032387 Trivex SystemSmith & Nephew, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 0 of its ownK212894 PhasTIPPLeMaitre Vascular, Inc. · 2022
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) | K964561 | Endolumina II Transillumination System 56FR E-5630, 50FR E-5030 and 40FR… | Bioenterics Corp. | 1997 | — |
| +1 | K991323 | Smith & Nephew Subcutaneous Illuminator | Smith & Nephew, Inc. | 1999 | — |
| +2 | K032387 | Trivex System | Smith & Nephew, Inc. | 2003 | 1 |
| +3 | K212894 | PhasTIPP | LeMaitre Vascular, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2022 | 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 FDG? 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? (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 |
|---|---|---|---|
| * | — | ENDOLUMINA® I Illuminated Bougie Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991323 | Smith & Nephew Subcutaneous Illuminator | 1999 | 2 |
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, K991323 (Smith & Nephew, Inc., 1999) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FDG devicesFDG Retractor, Fiberoptic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FDG
FDA has decided no FDG device since 2007.
Median 510(k) review, days · FDG
Too few FDG 510(k)s in any year since 2007 to give a median.
Recalls per year · FDG
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDG
2in 2025
MAUDE reports naming product code FDG, 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 | 4 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 13 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ENDOLUMINA II Transillumination System (EIB II) is a medical device designed to aid in the identification of the esophagus, rectum, and other structures by transillumination during laparoscopy, thoracoscopy, or open procedures.
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/K964561 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964561: Endolumina II Transillumination System 56FR E-5630, 50FR E-5030 and 40FR E-4020, Endolumina II Detachable Tips, 56FR, TA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964561
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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