510(k) · Cleared
Recalled · Class II · 2026Erbe's Tubing/Cap Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erbe USA, Inc. · OCX Endoscopic Irrigation/Suction System
Cleared on Aug 11, 2022 as substantially equivalent to K103696 (Erbe USA, Inc., 2011) and 1 other predicate after a 108-day review. Its family tree reaches back 6 generations to 1988. It has been recalled once.
- Decided
- Aug 11, 2022
- Review
- 108 days
- Class
- Class II
- Product code
- OCX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K884836 (1988). 11 ancestors in all, the oldest K790071 (1979). No later device cites it as a predicate yet.
- Root · 6 generations backK884836 Universal Generator Irrigator Model Ugi-3000Meditron Devices, Inc. · 1988
- 5 generations backK031773 Endo Gator SystemByrne Medical, Inc. · 2003
- 4 generations backK092429 EndogatorByrne Medical, Inc. · 2009
- 3 generations backK102855 Universal Irrigation Solution HybridByrne Medical, Inc. · 2010
- 2 generations backK132340 Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo…Erbe USA, Inc. · 2013 · Recalled
- 1 generation backK162152 Erbe’s CO2 Tubing/Cap SetsErbe USA, Inc. · 2016 · Recalled
- This deviceK221177 Erbe's Tubing/Cap SetsErbe USA, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K884836 | Universal Generator Irrigator Model Ugi-3000 | Meditron Devices, Inc. | 1988 | — |
| −5 | K031773 | Endo Gator System | Byrne Medical, Inc. | 2003 | — |
| −4 | K092429 | Endogator | Byrne Medical, Inc. | 2009 | — |
| −3 | K102855 | Universal Irrigation Solution Hybrid | Byrne Medical, Inc. | 2010 | — |
| −2 | K132340 | Erbeflo Clevercap Hybrid Tubing/Cap Set for Pentax Scopes, Erbeflo Clevercap… | Erbe USA, Inc. | 2013 | 1 |
| −1 | K162152 | Erbe’s CO2 Tubing/Cap Sets | Erbe USA, Inc. | 2016 | 1 |
| 0 (this device) | K221177 | Erbe's Tubing/Cap Sets | Erbe USA, Inc. | 2022 | — |
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 |
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 OCX? 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 OCX device
- #1 K251986 Auxiliary Water Tube Maj-855score 12.8 · 10 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 |
|---|---|---|---|
| * | K103696 | Erbeflo Clevercap Hybrid Tubing/Cap Sets for Olympus Models 160 and 180 Series ScopesSummary page 4…Predicate Devices: ERBEFLO CleverCap™ Hybrid Tubing/Cap Sets for Olympus® Model 160 and 180 Series Scopes, 510(k) Number K103696 and Erbe’s CO2 Tubing/Cap Sets, 510(k) Number K162152 Device Description: Erbe’s Tubing/Cap Se… | 2011 |
| * | K162152 | Erbe’s CO2 Tubing/Cap SetsSummary page 4…Model 160 and 180 Series Scopes, 510(k) Number K103696 and Erbe’s CO2 Tubing/Cap Sets, 510(k) Number K162152 Device Description: Erbe’s Tubing/Cap Sets are manufactured with medical grade materials or agents used in the medical device in… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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-2063-2026 | 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 34 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- 5 of the 11 ancestors have a recall of any class.
- 1 other device also cites its predicate K103696.
How does its category compare?
All OCX devicesOCX Endoscopic Irrigation/Suction System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OCX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCX
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCX
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCX
33in 2025
MAUDE reports naming product code OCX, 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 | 0 |
| 2010 | 3 | 51 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 4 | 256 | 0 | 1 |
| 2013 | 3 | 106 | 0 | 1 |
| 2014 | 6 | 77 | 0 | 5 |
| 2015 | 2 | — | 1 | 9 |
| 2016 | 2 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 5 | 60 | 0 | 18 |
| 2019 | 8 | 133 | 0 | 41 |
| 2020 | 4 | 88 | 11 | 11 |
| 2021 | 3 | 233 | 0 | 8 |
| 2022 | 6 | 84 | 2 | 18 |
| 2023 | 7 | 109 | 0 | 46 |
| 2024 | 4 | 74 | 0 | 21 |
| 2025 | 4 | 178 | 0 | 33 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Erbe Tubing/Cap/Cap Sets provide sterile water and air from a single source to an endoscope for 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/K221177 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221177: Erbe's 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/K221177
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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