Unimax Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Unimax Medical Systems, Inc.” (first 2011, latest 2021), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 158 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 | 1 | 168 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Unimax Medical Systems, Inc. took a median 168 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 4 | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
| OCT | Anti Fog Solution And Accessories, Endoscopy | 1 | 1 |
Review panels
Most recent Unimax Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211577 | SoftFix Balloon Trocar | GCJ | 2021-11-05 | 168 |
| K103508 | UNMIAX LAPAROSCOPIC INSTRUMENT | GEI | 2011-12-20 | 386 |
| K112358 | UNIMAX TROCAR SYSTEM | GCJ | 2011-10-17 | 62 |
| K111622 | UNIMAX ANTI-FOG SOLUTION | OCT | 2011-09-09 | 91 |
| K111441 | UNIMAX VERESS NEEDLE | HIF | 2011-08-19 | 87 |
| K103509 | UNIMAX SUCTION IRRIGATION SET | GCJ | 2011-05-19 | 171 |
| K103510 | UNIMAX SPECIMEN RETRIEVAL SYSTEM | GCJ | 2011-05-06 | 158 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2024-06-25.
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.
- Unimax Hearing Instruments (2 510(k)s)
- Unimax Medical Products Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Unimax Medical Systems, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Unimax Medical Systems, Inc.” (first 2011, latest 2021), across 4 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 Unimax Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Unimax Medical Systems, Inc. is 158 days.
Which FDA product codes appear under Unimax Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 4); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1); HIF (Insufflator, Laparoscopic, 1).
Next steps
- See all 7 Unimax Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Unimax Medical Systems, Inc.'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.