FDA product code FEO: Lithotriptor, Ultrasonic
FEO is the FDA product code for lithotriptor, ultrasonic. It is a Class II device, regulated under 21 CFR 876.4480 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 14 510(k) submissions under FEO, 1 in the last five years, from 7 different applicants. The average 510(k) review took 127 days (median 99). FDA has posted 7 recalls for FEO devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Lithotriptor, Ultrasonic |
| Device class | Class II |
| Regulation | 21 CFR 876.4480 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for FEO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 138 |
| 2018 | 4 | 47 |
| 2023 | 1 | 206 |
Compare with all 510(k) review times · Search every FEO clearance
Top FEO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E.M.S Electro Medical Systems S.A | 5 | 2023-10-23 |
| Cybersonics, Inc. | 2 | 2017-08-21 |
| Fibra Sonics, Inc. | 2 | 1999-11-22 |
| KARL STORZ Endoscopy-America, Inc. | 2 | 1998-06-22 |
| Richard Wolf Medical Instruments Corp. | 1 | 1992-12-07 |
2 more applicants have FEO clearances. See the full list in Caduvo.
Most recent FEO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230893 | E.M.S Electro Medical Systems S.A | Swiss LthoClast Trilogy | 2023-10-23 | 206 |
| K182490 | E.M.S Electro Medical Systems S.A | Swiss LithoClast Trilogy | 2018-10-09 | 28 |
| K181997 | E.M.S Electro Medical Systems S.A | Swiss LithoClast Trilogy | 2018-08-30 | 35 |
| K181364 | E.M.S Electro Medical Systems S.A | Swiss LithoClast Trilogy | 2018-06-20 | 28 |
| K173234 | E.M.S Electro Medical Systems S.A | Swiss LithoClast Trilogy | 2018-01-10 | 97 |
Recalls for FEO devices
7 product recalls in 5 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2026-01-08.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2022 | 1 |
| 2025 | 4 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code FEO?
FEO is the FDA product code for lithotriptor, ultrasonic. It is a Class II device, regulated under 21 CFR 876.4480 and reviewed by the Gastroenterology and Urology panel.
What device class is FEO?
Class II, regulation 21 CFR 876.4480. Typical premarket route: 510(k).
How long does a 510(k) take for product code FEO?
Across 14 cleared submissions the average was 127 days from receipt to decision (median 99).
Which companies have the most FEO clearances?
E.M.S Electro Medical Systems S.A (5); Cybersonics, Inc. (2); Fibra Sonics, Inc. (2); KARL STORZ Endoscopy-America, Inc. (2); Richard Wolf Medical Instruments Corp. (1).
Have FEO devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2026-01-08.
Next steps
- Run an FDA pathway report with predicate devices for product code FEO
- Run a recall and safety report across every FEO manufacturer
- Watch product code FEO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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