Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biophysic Medical, Inc. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
61 daysmedian FDA review time
144 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953399 | NEEDLE OR CUTTER | Biophysic Medical, Inc. | 1995-10-30 | 102 | 0 |
| K893035 | OPHTHASCAN 'S' MINI-A | Biophysic Medical, Inc. | 1989-06-12 | 49 | 0 |
| K890509 | INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM | Biophysic Medical, Inc. | 1989-03-24 | 51 | 0 |
| K884595 | OPHTHASCAN MINI-B | Biophysic Medical, Inc. | 1989-01-03 | 61 | 0 |
| K884456 | STERILE DISPOSABLE ENDOCULAR PROBE | Biophysic Medical, Inc. | 1988-12-09 | 46 | 0 |
| K883719 | INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM | Biophysic Medical, Inc. | 1988-10-18 | 48 | 0 |
| K881494 | FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER | Biophysic Medical, Inc. | 1988-08-30 | 144 | 0 |
| K881459 | NANOLAS ND:YAG OPHTHALMIC LASER | Biophysic Medical, Inc. | 1988-04-13 | 7 | 0 |
| K873460 | OPHTHALAS DYE OPHTHALMIC LASER | Biophysic Medical, Inc. | 1987-10-29 | 62 | 0 |
| K853116 | PAXIAL | Biophysic Medical, Inc. | 1985-10-31 | 98 | 0 |
| K844686 | OPHTHASCAN B | Biophysic Medical, Inc. | 1985-09-13 | 284 | 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