Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Paradigm Medical Industries, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
210 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050980 | ULTRASONIC BIO-MICROSCOPE, MODEL P60 | Paradigm Medical Industries, Inc. | 2005-05-26 | 37 | 0 |
| K023245 | BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01 | Paradigm Medical Industries, Inc. | 2002-10-21 | 21 | 0 |
| K003318 | PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X | Paradigm Medical Industries, Inc. | 2001-05-22 | 210 | 0 |
| K003141 | UBM PLUS, MODEL P45 | Paradigm Medical Industries, Inc. | 2000-12-05 | 56 | 0 |
| K002228 | PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-1317 | Paradigm Medical Industries, Inc. | 2000-10-06 | 74 | 0 |
| K981109 | QUITETIP | Paradigm Medical Industries, Inc. | 1998-06-09 | 74 | 0 |
| K974719 | PHACOPAK | Paradigm Medical Industries, Inc. | 1998-01-20 | 33 | 0 |
| K971795 | AUTOMATED CHAMBER MAINTENANCE MODULE | Paradigm Medical Industries, Inc. | 1997-07-14 | 60 | 0 |
| K970887 | BLOOD FLOW ANALYZER | Paradigm Medical Industries, Inc. | 1997-06-17 | 98 | 0 |
| K953447 | PRECISIONIST THIRTY THOUSAND | Paradigm Medical Industries, Inc. | 1995-10-13 | 88 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda