Data / Medical devices / United States / Erbe Medical, LLC
Erbe Medical, LLC: FDA-registered device maker in Tempe, AZ, United States, 6 510(k) clearances
Erbe Medical, LLC is registered with the FDA (registration 3020712480) in Tempe, AZ, United States. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 11, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3020712480
- Address
- 405 W Geneva Dr, Tempe, AZ, United States, 85282
- Owner or operator
- Erbe Medical, LLC (10083032)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 20, 2021
- Registered through
- 2026
- Brand names listed
- ERBEFLO AeroRinse® Air and Water Tubing/Cap Set for Fujinon® Scopes, ERBEFLO AeroRinse® Air and Water Tubing/Cap Set for Olympus® Scopes, ERBEFLO AeroRinse® Air and Water Tubing/Cap Set for Pentax® Scopes, ERBEFLO AeroRinse® CO2 and Water Tubing/Cap Set for Fujinon® Scopes, ERBEFLO AeroRinse® CO2 and Water Tubing/Cap Set for Olympus® Scopes, ERBEFLO AeroRinse® CO2 and Water Tubing/Cap Set for Olympus® Scopes & UCR, ERBEFLO AeroRinse® CO2 and Water Tubing/Cap Set for Pentax® Scopes, ERBEFLO CleverCap® CO2 Connector Tube and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscopic Irrigation/Suction System | OCX | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Pump, Air, Non-Manual, For Endoscope | FEQ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 11, 2022 | K221177 | Erbe's Tubing/Cap Sets | OCX | Substantially Equivalent | Erbe USA, Inc. | accessdata.fda.gov |
| June 27, 2019 | K191438 | ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector | OCX | Substantially Equivalent | Erbe USA, Inc. | accessdata.fda.gov |
| May 23, 2019 | K190469 | ERBEFLO 2 Disposable Tubing System | OCX | Substantially Equivalent | Erbe USA, Inc. | accessdata.fda.gov |
| November 6, 2018 | K182444 | ERBEFLO Olympus Scope Port Connector | OCX | Substantially Equivalent | Erbe USA, Inc. | accessdata.fda.gov |
| August 31, 2016 | K162152 | Erbes CO2 Tubing/Cap Sets | FEQ | Substantially Equivalent | Erbe USA, Inc. | accessdata.fda.gov |
| December 17, 2013 | K132340 | ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1 | FEQ | Substantially Equivalent | Erbe USA, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 31, 2026 | 98674 | Class II | Ongoing | ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20 | 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 use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distres | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Air, Non-Manual, For Endoscope
- All makers of Endoscopic Irrigation/Suction System
Updated May 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.