M. Imonti and Associates Inc.,: FDA clearances and approvals
M. Imonti and Associates Inc., has 6 FDA 510(k) clearances (first 1991, latest 1995), across 4 product codes in 3 review panels. Median 510(k) review time: 90 days.
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 |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | 3 | 3 |
| CBH | Device, Fixation, Tracheal Tube | 1 | 1 |
| GBX | Catheter, Irrigation | 1 | 1 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 1 | 1 |
Review panels
Most recent M. Imonti and Associates Inc., 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K950800 | PRO-PAK FOR OMS DIPLOMATE | HQC | 1995-05-22 | 90 |
| K950799 | PRO-VIT | HQE | 1995-04-28 | 66 |
| K933627 | PHACOFRAGMENTOR TIP | HQC | 1994-01-25 | 182 |
| K933503 | PRO-PHACO HANDPIECE | HQC | 1994-01-06 | 171 |
| K924551 | ENDO TRACHEA TUBE FIXATION | CBH | 1992-12-08 | 90 |
| K905766 | DRAINAGE TUBE RESTRAINT/WOUND COVER | GBX | 1991-03-06 | 69 |
Recalls
openFDA lists no recalls under a recalling firm named M. Imonti and Associates Inc.,.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does M. Imonti and Associates Inc., have?
M. Imonti and Associates Inc., has 6 FDA 510(k) clearances (first 1991, latest 1995), across 4 product codes in 3 review panels.
How long does FDA take to clear M. Imonti and Associates Inc.,'s 510(k)s?
The median time from FDA receipt to decision across M. Imonti and Associates Inc.,'s cleared 510(k)s is 90 days.
What devices does M. Imonti and Associates Inc., make?
Its most frequent FDA product codes are HQC (Unit, Phacofragmentation, 3); CBH (Device, Fixation, Tracheal Tube, 1); GBX (Catheter, Irrigation, 1).
Has M. Imonti and Associates Inc., had device recalls?
openFDA lists no recalls under a recalling firm name matching M. Imonti and Associates Inc.,. Related entities may recall under other names.
Next steps
- See all 6 M. Imonti and Associates Inc., clearances with predicates and recalls
- Run predicate analysis for product code HQC, M. Imonti and Associates Inc.,'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.