510(k) · Cleared
Recalled · Class II · 2026Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2 Tubing/Cap Set for Olympus 160/1
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 Dec 17, 2013 as substantially equivalent to K102855 (Byrne Medical, Inc., 2010) and 1 other predicate after a 144-day review. Its family tree reaches back 4 generations to 1988. 2 later devices descend from it. It has been recalled once.
- Decided
- Dec 17, 2013
- Review
- 144 days
- Class
- Class II
- Product code
- FEQ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K884836 (1988). 9 ancestors in all, the oldest K790071 (1979). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK884836 Universal Generator Irrigator Model Ugi-3000Meditron Devices, Inc. · 1988
- 3 generations backK031773 Endo Gator SystemByrne Medical, Inc. · 2003
- 2 generations backK092429 EndogatorByrne Medical, Inc. · 2009
- 1 generation backK102855 Universal Irrigation Solution HybridByrne Medical, Inc. · 2010
- This deviceK132340 Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo…Erbe USA, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK162152 Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK221177 Erbe's Tubing/Cap SetsErbe USA, Inc. · 2022 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K884836 | Universal Generator Irrigator Model Ugi-3000 | Meditron Devices, Inc. | 1988 | — |
| −3 | K031773 | Endo Gator System | Byrne Medical, Inc. | 2003 | — |
| −2 | K092429 | Endogator | Byrne Medical, Inc. | 2009 | — |
| −1 | K102855 | Universal Irrigation Solution Hybrid | Byrne Medical, Inc. | 2010 | — |
| 0 (this device) | K132340 | Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap… | Erbe USA, Inc. | 2013 | — |
| +1 | K162152 | Erbe’s CO2 Tubing/Cap Sets | Erbe USA, Inc. | 2016 | 1 |
| +2 | 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 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K102855 | Universal Irrigation Solution HybridSummary page 1…00) Product Code: FEG Legally Marketed Predicate Device:. Universal Irrigation Solution Hybrid TM , 510(k) Number K102855 and ERBEFLO CleverCap® Hybrid Tubing/Cap Sets, 510(k) Number K103696 Device Description: In general… | 2010 |
| * | K103696 | Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series ScopesSummary page 1…igation Solution Hybrid TM , 510(k) Number K102855 and ERBEFLO CleverCap® Hybrid Tubing/Cap Sets, 510(k) Number K103696 Device Description: In general; the Hybrid CO 2 Tubing/Cap Sets and 002 Connector Tubes will be manufactured with medical grade… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162152 | Erbe’s CO2 Tubing/Cap Sets | 2016 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 31, 2026 | Class II | Z-2062-2026 | Component change control | Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K162152 (Erbe USA, Inc., 2016) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K102855.
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. 2013, 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 EIIBEFLO CleverCap Hybrid CO2 Tubing/Cap Sets and CO2 Connector Tube provide sterile
water and CO2 or air (if CO2 is not used) to an endoscope for endoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132340 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132340: Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2 Tubing/Cap Set for Olympus 160/1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132340
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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