510(k) · Cleared
ClearedLsi Endoscopic External Accessory Channel and Accessories Product
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lsi Solutions · ODC Endoscope Channel Accessory
Cleared on Mar 24, 2003 as substantially equivalent to K011016 (Lsi Solutions, 2001) after a 90-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- Mar 24, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- ODC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011016 (2001). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK011016 Lsi Solutions Flexible Suture Placement Device and Accessories ProductLsi Solutions · 2001 · Recalled
- This deviceK024301 Lsi Endoscopic External Accessory Channel and Accessories ProductLsi Solutions · 2003
- Descendant · cites it directly · 1 of its ownK033695 Irrigation Channel Tubing, Model 100135Byrne Medical, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK092461 Irrigation Pump, Irrigation Biopsy Valve, ,Model 00711520, 00711139…United States Endoscopy Group, Inc. · 2009 · Recalled
- Descendant · cites it directly · 0 of its ownK073484 Ethicon Endo Surgery Sheath and Articulating Accessory Channel -…Ethicon Endo-Surgery, Inc. · 2008
Most influential descendants
Showing 3 of 3 · See all- K033695Irrigation Channel Tubing, Model 100135Byrne Medical, Inc. · 2003 · cites it directly1descendant
- K092461Irrigation Pump, Irrigation Biopsy Valve, ,Model 00711520, 00711139, 00711140United States Endoscopy Group, Inc. · 2009 · 2 generations on0descendants
- K073484Ethicon Endo Surgery Sheath and Articulating Accessory Channel - Gastroscope, Model…Ethicon Endo-Surgery, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011016 | Lsi Solutions Flexible Suture Placement Device and Accessories Product | Lsi Solutions | 2001 | 1 |
| 0 (this device) | K024301 | Lsi Endoscopic External Accessory Channel and Accessories Product | Lsi Solutions | 2003 | — |
| +1 | K033695 | Irrigation Channel Tubing, Model 100135 | Byrne Medical, Inc. | 2003 | — |
| +2 | K092461 | Irrigation Pump, Irrigation Biopsy Valve, ,Model 00711520, 00711139, 00711140 | United States Endoscopy Group, Inc. | 2009 | 1 |
| +1 | K073484 | Ethicon Endo Surgery Sheath and Articulating Accessory Channel - Gastroscope… | Ethicon Endo-Surgery, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 ODC? 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 ODC device
- #1 K232329 Defendo Fujifilm 700 Single Use Biopsy Valve…score 14.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K011016 | Lsi Solutions Flexible Suture Placement Device and Accessories ProductSummary page 3…ernal Accessory Channel and Accessories Product Endoscope and accessories (per 21 CFR §876.1500) LSI soLuTiONS Flexible Suture Placement Device and Accessories Product (K011016) The LSI Endoscopic External Accessory Channel and Accessories Product is a sterile conduit that can be safely attached to commo… | 2001 |
What descends from it? (3)
2 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?
How does its category compare?
All ODC devicesODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ODC
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODC
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODC
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODC
91in 2025
MAUDE reports naming product code ODC, 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 | 3 | 83 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 67 | 0 | 0 |
| 2011 | 4 | 143 | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 8 |
| 2017 | 1 | — | 0 | 12 |
| 2018 | 2 | — | 0 | 17 |
| 2019 | 4 | 55 | 0 | 40 |
| 2020 | 4 | 128 | 0 | 54 |
| 2021 | 6 | 181 | 0 | 52 |
| 2022 | 8 | 118 | 0 | 37 |
| 2023 | 7 | 126 | 0 | 43 |
| 2024 | 8 | 95 | 0 | 100 |
| 2025 | 6 | 106 | 0 | 91 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The LSI Endoscopic External Accessory Channel and Accessories Product is intended for use as a supplemental conduit that attaches to an endoscope to enable improved access during endoscopic 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/K024301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024301: Lsi Endoscopic External Accessory Channel and Accessories Product.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024301
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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