510(k) · Cleared
Recalled · Class II · 2019Endo Smartcap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Byrne Medical, Inc. · FAJ Cystoscope And Accessories, Flexible/Rigid
Cleared on Dec 15, 2009 as substantially equivalent to K790071 (Olympus Corp., 1979) and 1 other predicate after a 20-day review. Its family tree reaches back 1 generation to 1979. 18 later devices descend from it. It has been recalled 7 times.
- Decided
- Dec 15, 2009
- Review
- 20 days
- Class
- Class II
- Product code
- FAJ
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 1 generation to K790071 (1979). 2 ancestors in all. 18 later devices descend from it, 9 citing it directly.
- Root · 1 generation backK790071 Endoscope and AccessoriesOlympus Corp. · 1979 · Recalled
- This deviceK093665 Endo SmartcapByrne Medical, Inc. · 2009
- Descendant · cites it directly · 7 of its ownK102855 Universal Irrigation Solution HybridByrne Medical, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK103696 Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and…Erbe USA, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK132340 Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo…Erbe USA, Inc. · 2013 · Recalled
- Descendant · cites it directly · 1 of its ownK203350 ENDOtubeNissha Medical Technologies Sas · 2021
- Descendant · 3 generations on · 1 of its ownK162152 Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc. · 2016 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K102855Universal Irrigation Solution HybridByrne Medical, Inc. · 2010 · cites it directly7descendants
- K103696Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series ScopesErbe USA, Inc. · 2011 · cites it directly3descendants
- K132340Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2…Erbe USA, Inc. · 2013 · 2 generations on2descendants
- K203350ENDOtubeNissha Medical Technologies Sas · 2021 · cites it directly1descendant
- K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc. · 2016 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K790071 | Endoscope and Accessories | Olympus Corp. | 1979 | 6 |
| 0 (this device) | K093665 | Endo Smartcap | Byrne Medical, Inc. | 2009 | — |
| +1 | K102855 | Universal Irrigation Solution Hybrid | Byrne Medical, Inc. | 2010 | — |
| +1 | K103696 | Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series… | Erbe USA, Inc. | 2011 | — |
| +2 | K132340 | Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap… | Erbe USA, Inc. | 2013 | 1 |
| +1 | K203350 | ENDOtube | Nissha Medical Technologies Sas | 2021 | — |
| +3 | K162152 | Erbe’s CO2 Tubing/Cap Sets | Erbe USA, Inc. | 2016 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 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 FAJ? 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 FAJ device
- #1 K193095 Ambu aScope 4 Cystoscore 31.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K790071 | Endoscope and AccessoriesSummary page 4…e | Endoscopes and Accessories, KOG, 21 CFR §876.1500, TABLE 3 — Predicate Devices Device Manufacturer 510(k} Number MD-431 Water Bottle Oiymbus Corp Center Valley, PA K790071 Endo SmartCap™ Endo SmartCap™ Company Houston, TX K971125 Endo SmartCap™ Premarket NotHication / §5 — 510(k) Summary - pg. 1 | 1979 |
| * | K971125 | Endo Smartcap (100501)Summary page 4…BLE 3 — Predicate Devices Device Manufacturer 510(k} Number MD-431 Water Bottle Oiymbus Corp Center Valley, PA K790071 Endo SmartCap™ Endo SmartCap™ Company Houston, TX K971125 Endo SmartCap™ Premarket NotHication / §5 — 510(k) Summary - pg. 1 | 1997 |
What descends from it? (18)
See all 189 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102855 | Universal Irrigation Solution Hybrid | 2010 | 7 |
| K103696 | Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series Scopes | 2011 | 3 |
| K203350 | ENDOtube | 2021 | 1 |
| K140753 | Endo Smart Bottle, Rinse and Insufflation System | 2014 | 1 |
| K242357 | Water Container (MAJ-901); Water Container (MAJ-902) | 2024 | 0 |
| K231471 | Air/Water Bottle Tubing, CO2 Source Tubing | 2023 | 0 |
| K223040 | Endo SmartCap | 2023 | 0 |
| K200388 | Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector | 2020 | 0 |
| K191282 | PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 9, 2019 | Class II | Z-1777-2020 | Equipment maintenance | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope… |
| Oct 9, 2019 | Class II | Z-1772-2020 | Equipment maintenance | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope… |
| Oct 9, 2019 | Class II | Z-1776-2020 | Equipment maintenance | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope… |
| Oct 9, 2019 | Class II | Z-1773-2020 | Equipment maintenance | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope… |
| Oct 9, 2019 | Class II | Z-1778-2020 | Equipment maintenance | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope… |
| Oct 9, 2019 | Class II | Z-1775-2020 | Equipment maintenance | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope… |
| Oct 9, 2019 | Class II | Z-1774-2020 | Equipment maintenance | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All FAJ devicesFAJ Cystoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FAJ
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAJ
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAJ
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAJ
2,690in 2025
MAUDE reports naming product code FAJ, 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 | 2 | — | 0 | 9 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 2 | — | 0 | 10 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 28 |
| 2016 | 1 | — | 0 | 75 |
| 2017 | 2 | — | 1 | 79 |
| 2018 | 2 | — | 0 | 79 |
| 2019 | 3 | 207 | 0 | 102 |
| 2020 | 2 | — | 0 | 339 |
| 2021 | 3 | 127 | 0 | 494 |
| 2022 | 5 | 170 | 1 | 744 |
| 2023 | 5 | 207 | 7 | 920 |
| 2024 | 9 | 130 | 0 | 892 |
| 2025 | 8 | 98 | 0 | 2,690 |
| 2026 | 5 | 123 | 0 | — |
What is it indicated for?
The Endo SmartCap™ is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope 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/K093665 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093665: Endo Smartcap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093665
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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