510(k) · Cleared
ClearedErbeflo 2 Disposable Tubing System
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 Dec 23, 2010 as substantially equivalent to K924102 (United States Endoscopy Group, Inc., 1992) after a 51-day review. Its family tree reaches back 1 generation to 1992. 4 later devices descend from it.
- Decided
- Dec 23, 2010
- Review
- 51 days
- Class
- Class II
- Product code
- OCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K924102 (1992). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK924102 NeedleUnited States Endoscopy Group, Inc. · 1992
- This deviceK103235 Erbeflo 2 Disposable Tubing SystemErbe USA, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK143186 Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect…Erbe USA, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK191438 ERBEFLO 2 Endo Quick Connect Pentax Scope Port ConnectorErbe USA, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK190469 ERBEFLO 2 Disposable Tubing SystemErbe USA, Inc. · 2019 · Recalled
- Descendant · cites it directly · 0 of its ownK182444 ERBEFLO Olympus Scope Port ConnectorErbe USA, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K143186Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port…Erbe USA, Inc. · 2014 · cites it directly1descendant
- K191438ERBEFLO 2 Endo Quick Connect Pentax Scope Port ConnectorErbe USA, Inc. · 2019 · 2 generations on0descendants
- K190469ERBEFLO 2 Disposable Tubing SystemErbe USA, Inc. · 2019 · cites it directly0descendants
- K182444ERBEFLO Olympus Scope Port ConnectorErbe USA, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924102 | Needle | United States Endoscopy Group, Inc. | 1992 | — |
| 0 (this device) | K103235 | Erbeflo 2 Disposable Tubing System | Erbe USA, Inc. | 2010 | — |
| +1 | K143186 | Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope… | Erbe USA, Inc. | 2014 | — |
| +2 | K191438 | ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector | Erbe USA, Inc. | 2019 | — |
| +1 | K190469 | ERBEFLO 2 Disposable Tubing System | Erbe USA, Inc. | 2019 | 1 |
| +1 | K182444 | ERBEFLO Olympus Scope Port Connector | Erbe USA, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 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? (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 |
|---|---|---|---|
| * | K924102 | NeedleSummary page 1…Endoscopes And/or Accessories (21 CFR Part 876.1500) Product Code: KOG Legally Marketed Predicate Device: EndoGatorG System, 51 0(k) Number K924102 EndoGator is a registered trademark of Byrne Medical, Inc. Device Description: The ERBEFLOTM 2 Disposable Tubing System consist… | 1992 |
What descends from it? (4)
3 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?
How does its category compare?
All OCX devicesOCX Endoscopic Irrigation/Suction System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 ERBEFLOTM 2 Disposable Tubing System is intended to provide sterile water from a water source through an irrigation pump and an endoscope (or to an endoscope) for endoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103235: Erbeflo 2 Disposable Tubing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103235
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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