Med-Logics, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Med-Logics, Inc.” (first 1996, latest 2004), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 82 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 |
|---|---|---|---|
| HNO | Keratome, Ac-Powered | 7 | 7 |
| KYG | Device, Irrigation, Ocular Surgery | 2 | 2 |
| MSR | Tubing, Replacement, Phacofragmentation Unit | 2 | 2 |
| HOZ | Sponge, Ophthalmic | 1 | 1 |
Review panels
- Ophthalmic (12)
Most recent Med-Logics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033293 | MED-LOGICS, MODEL ML7090 | HNO | 2004-01-13 | 91 |
| K022982 | MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB | HNO | 2002-11-15 | 67 |
| K022716 | MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB | HNO | 2002-10-11 | 57 |
| K010872 | ML BLADE, MODEL ML7030 | HNO | 2001-06-22 | 91 |
| K010353 | MED-LOGICS DISPOSABLE ALK TUBING | KYG | 2001-04-27 | 80 |
| K002515 | MEDLOGICS ML 4000, MODEL 4000 | HNO | 2001-02-22 | 191 |
| K002279 | ML EYE SPEAR, MODEL ML 27 ES | HOZ | 2000-08-18 | 23 |
| K983448 | ML UNIVERSAL TUBING | MSR | 1998-12-18 | 79 |
| K981071 | ML MICROKERATOME | HNO | 1998-07-23 | 121 |
| K972522 | ML-DISPOSABLE PAK | MSR | 1997-09-30 | 85 |
2 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2015-01-13.
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 Med-Logics, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Med-Logics, Inc.” (first 1996, latest 2004), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Med-Logics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Med-Logics, Inc. is 82 days.
Which FDA product codes appear under Med-Logics, Inc.?
The most frequent FDA product codes under this applicant name are HNO (Keratome, Ac-Powered, 7); KYG (Device, Irrigation, Ocular Surgery, 2); MSR (Tubing, Replacement, Phacofragmentation Unit, 2).
Next steps
- See all 12 Med-Logics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HNO, Med-Logics, 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.