Sterne Equipment Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Sterne Equipment Co., Ltd.” (first 1989, latest 2001), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 207 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | 3 | 3 |
| IZL | System, X-Ray, Mobile | 2 | 2 |
| LIH | Interferential Current Therapy | 1 | 1 |
Review panels
- Physical Medicine (3)
- Radiology (2)
- Neurology (1)
Most recent Sterne Equipment Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003433 | NEURO-TRAIN III (3) | IPF | 2001-06-15 | 221 |
| K980158 | MYO-TRAIN V (5) | IPF | 1998-07-28 | 193 |
| K972204 | ACU-RAY HF SERIES PORTABLE X-RAY UNIT | IZL | 1997-10-08 | 118 |
| K970155 | NEURO-TRAIN II (2) | IPF | 1997-03-17 | 60 |
| K931279 | ACU-RAY | IZL | 1993-11-03 | 240 |
| K883896 | NEUROTRAIN | LIH | 1989-07-14 | 303 |
Recalls
openFDA lists no recalls under a recalling firm named Sterne Equipment Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sterne Medical Equipment Div. Ontario , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sterne Equipment Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Sterne Equipment Co., Ltd.” (first 1989, latest 2001), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sterne Equipment Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sterne Equipment Co., Ltd. is 207 days.
Which FDA product codes appear under Sterne Equipment Co., Ltd.?
The most frequent FDA product codes under this applicant name are IPF (Stimulator, Muscle, Powered, 3); IZL (System, X-Ray, Mobile, 2); LIH (Interferential Current Therapy, 1).
Next steps
- See all 6 Sterne Equipment Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IPF, Sterne Equipment Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.