Goodman Co., Ltd.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Goodman Co., Ltd.” (first 2001, latest 2025), plus 1 PMA decision, across 3 product codes in 2 review panels. Median 510(k) review time under this name: 123 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 | 1 | 266 |
| 2025 | 1 | 123 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Goodman Co., Ltd. took a median 194 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 127 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PNO | Catheter, Percutaneous, Cutting/Scoring | 2 | 2 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| NWX | Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring | 1 | 0 |
Review panels
- Cardiovascular (3)
- Radiology (1)
Most recent Goodman Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243944 | Aperta NSE PTA Balloon Dilatation Catheter | PNO | 2025-04-22 | 123 |
| K232013 | Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040) | PNO | 2024-03-28 | 266 |
| K010763 | GOODNET | LLZ | 2001-05-25 | 72 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P230026 | PMA | Lacrosse NSE ALPHA Coronary Dilatation Catheter | 2024-06-06 |
Recalls
openFDA lists no recalls under a recalling firm named Goodman 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.
- Goodman, Goodman & Goodman (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Goodman Co., Ltd.?
FDA lists 3 510(k) clearances under the applicant name “Goodman Co., Ltd.” (first 2001, latest 2025), plus 1 PMA decision, across 3 product codes in 2 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 Goodman Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Goodman Co., Ltd. is 123 days.
Which FDA product codes appear under Goodman Co., Ltd.?
The most frequent FDA product codes under this applicant name are PNO (Catheter, Percutaneous, Cutting/Scoring, 2); LLZ (System, Image Processing, Radiological, 1); NWX (Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring, 1).
Next steps
- See all 3 Goodman Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code PNO, Goodman 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.