510(k) · Cleared
Recalled · Class II · 2026Erbe’s CO2 Tubing/Cap Sets
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 Aug 31, 2016 as substantially equivalent to K132340 (Erbe USA, Inc., 2013) after a 29-day review. Its family tree reaches back 5 generations to 1988. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 31, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- FEQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K884836 (1988). 10 ancestors in all, the oldest K790071 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK884836 Universal Generator Irrigator Model Ugi-3000Meditron Devices, Inc. · 1988
- 4 generations backK031773 Endo Gator SystemByrne Medical, Inc. · 2003
- 3 generations backK092429 EndogatorByrne Medical, Inc. · 2009
- 2 generations backK102855 Universal Irrigation Solution HybridByrne Medical, Inc. · 2010
- 1 generation backK132340 Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo…Erbe USA, Inc. · 2013 · Recalled
- This deviceK162152 Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK221177 Erbe's Tubing/Cap SetsErbe USA, Inc. · 2022 · Recalled
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −5 | K884836 | Universal Generator Irrigator Model Ugi-3000 | Meditron Devices, Inc. | 1988 | — |
| −4 | K031773 | Endo Gator System | Byrne Medical, Inc. | 2003 | — |
| −3 | K092429 | Endogator | Byrne Medical, Inc. | 2009 | — |
| −2 | K102855 | Universal Irrigation Solution Hybrid | Byrne Medical, Inc. | 2010 | — |
| −1 | K132340 | Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap… | Erbe USA, Inc. | 2013 | 1 |
| 0 (this device) | K162152 | Erbe’s CO2 Tubing/Cap Sets | Erbe USA, Inc. | 2016 | — |
| +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 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K132340 | Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2…Summary page 4…FEQ Legally Marketed Predicate Device: ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Sets and Connector Tube, 510(k) Number K132340 Device Description: In general; Erbe’s CO2 Tubing/Cap Sets will be manufactured with medical grade materials or agents used in t… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221177 | Erbe's Tubing/Cap Sets | 2022 | 0 |
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 28 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K221177 (Erbe USA, Inc., 2022) has gone furthest, with 0 descendants of its own.
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. 2016, 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?
Erbe's CO2 Tubing/Cap Sets 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/K162152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162152: Erbe’s CO2 Tubing/Cap Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162152
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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