Erbe USA, Inc.: FDA clearances and approvals
Erbe USA, Inc. has 39 FDA 510(k) clearances (first 1994, latest 2022), across 5 product codes in 3 review panels. Median 510(k) review time: 58 days. Since 2017 its median was 73 days, against 109 days for all cleared 510(k)s in the same product codes. openFDA lists 4 product recalls by a recalling firm named Erbe USA, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 100 |
| 2014 | 1 | 43 |
| 2015 | 2 | 178 |
| 2016 | 1 | 29 |
| 2017 | 0 | — |
| 2018 | 1 | 60 |
| 2019 | 2 | 57 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 108 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Erbe USA, Inc.'s cleared 510(k)s took a median 73 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 109 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 25 | 25 |
| OCX | Endoscopic Irrigation/Suction System | 6 | 6 |
| FEQ | Pump, Air, Non-Manual, For Endoscope | 3 | 3 |
| FQH | Lavage, Jet | 3 | 3 |
| GEH | Unit, Cryosurgical, Accessories | 2 | 2 |
Review panels
Most recent Erbe USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221177 | Erbe's Tubing/Cap Sets | OCX | 2022-08-11 | 108 |
| K191438 | ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector | OCX | 2019-06-27 | 28 |
| K190469 | ERBEFLO 2 Disposable Tubing System | OCX | 2019-05-23 | 86 |
| K182444 | ERBEFLO Olympus Scope Port Connector | OCX | 2018-11-06 | 60 |
| K162152 | Erbes CO2 Tubing/Cap Sets | FEQ | 2016-08-31 | 29 |
| K143306 | ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe | GEI | 2015-10-27 | 343 |
| K151041 | ERBECRYO 2 Cryosurgical Unit with accessories | GEH | 2015-05-04 | 14 |
| K143186 | Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector | OCX | 2014-12-18 | 43 |
| K132340 | ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1 | FEQ | 2013-12-17 | 144 |
| K133180 | ERBE ESU MODEL VIO DV WITH ACCESSORIES | GEI | 2013-12-11 | 55 |
29 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 2 recall events; 4 initiated in the last five years. Most recent: 2026-06-26.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Erbe USA, Inc. have?
Erbe USA, Inc. has 39 FDA 510(k) clearances (first 1994, latest 2022), across 5 product codes in 3 review panels.
How long does FDA take to clear Erbe USA, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Erbe USA, Inc.'s cleared 510(k)s is 58 days. Since 2017: 73 days, versus 109 days for all cleared 510(k)s in the same product codes.
What devices does Erbe USA, Inc. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 25); OCX (Endoscopic Irrigation/Suction System, 6); FEQ (Pump, Air, Non-Manual, For Endoscope, 3).
Has Erbe USA, Inc. had device recalls?
openFDA lists 4 product recalls in 2 recall events by a recalling firm whose name matches Erbe USA, Inc; the most recent began 2026-06-26. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 39 Erbe USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Erbe USA, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.