Unimar, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Unimar, Inc.” (first 1981, latest 1994), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 86 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 |
|---|---|---|---|
| EYY | Drape, Urological, Disposable | 1 | 1 |
| HDR | Cap, Cervical | 1 | 1 |
| HES | Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) | 1 | 1 |
| HFC | Aspirator, Endocervical | 1 | 1 |
| HHK | Curette, Suction, Endometrial (And Accessories) | 1 | 1 |
| HHT | Spatula, Cervical, Cytological | 1 | 1 |
| HIB | Speculum, Vaginal, Nonmetal | 1 | 1 |
| HIG | Insufflator, Hysteroscopic | 1 | 1 |
| LKF | Cannula, Manipulator/Injector, Uterine | 1 | 1 |
| MFD | Cannula, Intrauterine Insemination | 1 | 1 |
Review panels
Most recent Unimar, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932432 | KRONNER REINFORCING STYLETTE | LKF | 1994-04-12 | 327 |
| K920803 | HSG TRAY | HIB | 1992-10-19 | 241 |
| K910317 | UNI-SEM(TM) | MFD | 1991-05-01 | 97 |
| K904473 | KRONNER MANIPUJECTOR | HES | 1990-12-14 | 74 |
| K895659 | HUI MINI-FLEX | HIG | 1989-12-19 | 90 |
| K895403 | ASPIRETTE ENDOCERVICAL ASPIRATOR | HFC | 1989-11-29 | 83 |
| K894264 | KDF-2.3 | HDR | 1989-08-15 | 56 |
| K890848 | CERVEX-BRUSH | HHT | 1989-05-11 | 79 |
| K854415 | ENDOMETRIAL PIPELLE | HHK | 1986-03-13 | 129 |
| K810291 | STERILE/DISPOSABLE HSG TRAY | EYY | 1981-03-18 | 43 |
Recalls
openFDA lists no recalls under a recalling firm named Unimar, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Unimar, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Unimar, Inc.” (first 1981, latest 1994), across 10 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 Unimar, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Unimar, Inc. is 86 days.
Which FDA product codes appear under Unimar, Inc.?
The most frequent FDA product codes under this applicant name are EYY (Drape, Urological, Disposable, 1); HDR (Cap, Cervical, 1); HES (Insufflator, Carbon-Dioxide, Uterotubal (And Accessories), 1).
Next steps
- See all 10 Unimar, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EYY, Unimar, 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.