Paradigm Medical Industries, Inc.: FDA clearances and approvals
Paradigm Medical Industries, Inc. has 10 FDA 510(k) clearances (first 1995, latest 2005), across 5 product codes in 3 review panels. Median 510(k) review time: 67 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 | 4 | 4 |
| GEX | Powered Laser Surgical Instrument | 2 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
| HKY | Tonometer, Manual | 1 | 1 |
| NJJ | Tonometer, Analyzer, Ocular Blood Flow | 1 | 1 |
Review panels
- Ophthalmic (6)
- Radiology (2)
- General and Plastic Surgery (2)
Most recent Paradigm Medical Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050980 | ULTRASONIC BIO-MICROSCOPE, MODEL P60 | IYO | 2005-05-26 | 37 |
| K023245 | BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01 | NJJ | 2002-10-21 | 21 |
| K003318 | PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X | GEX | 2001-05-22 | 210 |
| K003141 | UBM PLUS, MODEL P45 | IYO | 2000-12-05 | 56 |
| K002228 | PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X | GEX | 2000-10-06 | 74 |
| K981109 | QUITETIP | HQC | 1998-06-09 | 74 |
| K974719 | PHACOPAK | HQC | 1998-01-20 | 33 |
| K971795 | AUTOMATED CHAMBER MAINTENANCE MODULE | HQC | 1997-07-14 | 60 |
| K970887 | BLOOD FLOW ANALYZER | HKY | 1997-06-17 | 98 |
| K953447 | PRECISIONIST THIRTY THOUSAND | HQC | 1995-10-13 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Paradigm Medical Industries, 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 Paradigm Medical Industries, Inc. have?
Paradigm Medical Industries, Inc. has 10 FDA 510(k) clearances (first 1995, latest 2005), across 5 product codes in 3 review panels.
How long does FDA take to clear Paradigm Medical Industries, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Paradigm Medical Industries, Inc.'s cleared 510(k)s is 67 days.
What devices does Paradigm Medical Industries, Inc. make?
Its most frequent FDA product codes are HQC (Unit, Phacofragmentation, 4); GEX (Powered Laser Surgical Instrument, 2); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 2).
Has Paradigm Medical Industries, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Paradigm Medical Industries, Inc. Related entities may recall under other names.
Next steps
- See all 10 Paradigm Medical Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQC, Paradigm Medical Industries, 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.