Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Physician Industries, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K040565 | PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE | Physician Industries, Inc. | 2004-07-22 | 141 | 0 |
| K033739 | PHYSICIAN INDUSTRIES' DURAMETER SYRINGE | Physician Industries, Inc. | 2004-07-12 | 227 | 0 |
| K960248 | GENERAL PROCEDURE KIT | Physician Industries, Inc. | 1996-04-12 | 87 | 33 |
| K954068 | GENERAL HYGIENE KIT | Physician Industries, Inc. | 1995-11-08 | 70 | 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