510(k) · Cleared
ClearedErbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series Scopes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erbe USA, Inc. · FEQ Pump, Air, Non-Manual, For Endoscope
Cleared on Mar 22, 2011 as substantially equivalent to K092429 (Byrne Medical, Inc., 2009) and 1 other predicate after a 95-day review. Its family tree reaches back 3 generations to 1988. 3 later devices descend from it.
- Decided
- Mar 22, 2011
- Review
- 95 days
- Class
- Class II
- Product code
- FEQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K884836 (1988). 7 ancestors in all, the oldest K790071 (1979). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK884836 Universal Generator Irrigator Model Ugi-3000Meditron Devices, Inc. · 1988
- 2 generations backK031773 Endo Gator SystemByrne Medical, Inc. · 2003
- 1 generation backK092429 EndogatorByrne Medical, Inc. · 2009
- This deviceK103696 Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and…Erbe USA, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK132340 Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo…Erbe USA, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 1 of its ownK162152 Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc. · 2016 · Recalled
- Descendant · cites it directly · 0 of its ownK221177 Erbe's Tubing/Cap SetsErbe USA, Inc. · 2022 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K132340Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2…Erbe USA, Inc. · 2013 · cites it directly2descendants
- K162152Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc. · 2016 · 2 generations on1descendant
- K221177Erbe's Tubing/Cap SetsErbe USA, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K884836 | Universal Generator Irrigator Model Ugi-3000 | Meditron Devices, Inc. | 1988 | — |
| −2 | K031773 | Endo Gator System | Byrne Medical, Inc. | 2003 | — |
| −1 | K092429 | Endogator | Byrne Medical, Inc. | 2009 | — |
| 0 (this device) | K103696 | Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series… | Erbe USA, Inc. | 2011 | — |
| +1 | K132340 | Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap… | Erbe USA, Inc. | 2013 | 1 |
| +2 | K162152 | Erbe’s CO2 Tubing/Cap Sets | Erbe USA, Inc. | 2016 | 1 |
| +1 | K221177 | Erbe's Tubing/Cap Sets | Erbe USA, Inc. | 2022 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 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 FEQ? 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 FEQ device
- #1 K220395 EndoGator Endoscopy Irrigation Tubingscore 15.6 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K092429 | EndogatorSummary page 1…Endoscopes And/or Accessories (21 CFR Part 876.1500) Product Code: KOG Legally Marketed Predicate Device: EndoGator@® System, 510(k) Number K092429 and Endo SmartCap@, K093665. EndoGator and Endo SmartCap are registered trademarks of Byrne Medical,… | 2009 |
| * | K093665 | Endo SmartcapSummary page 1…00) Product Code: KOG Legally Marketed Predicate Device: EndoGator@® System, 510(k) Number K092429 and Endo SmartCap@, K093665. EndoGator and Endo SmartCap are registered trademarks of Byrne Medical, Inc. Device Description: The ERBEFLO CleverCap Hybrid… | 2009 |
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?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K132340 (Erbe USA, Inc., 2013) has gone furthest, with 2 descendants of its own.
- 12 other devices also cite its predicate K092429.
How does its category compare?
All FEQ devicesFEQ Pump, Air, Non-Manual, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · FEQ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · FEQ
29in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FEQ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FEQ
341in 2025
MAUDE reports naming product code FEQ, 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 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 3 | 84 | 0 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 3 | 141 | 0 | 2 |
| 2013 | 1 | — | 1 | 4 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 2 | — | 1 | 1 |
| 2016 | 3 | 29 | 0 | 1 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 0 | 22 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 1 | — | 0 | 19 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 0 | — | 1 | 705 |
| 2025 | 0 | — | 0 | 341 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The ERBEFLO CleverCapTM Hybrid Tubing/Cap Sets provide sterile water and air from a single source to an endoscope for endoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103696: Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series Scopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103696
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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