Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MQU · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000151 | PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE | Integrated Orbital Implants, Inc. | 2000-04-10 | 82 | 0 |
| K980822 | TITANIUM PEG SYSTEM | Fci Ophthalmics, Inc. | 1998-07-09 | 128 | 0 |
| K974203 | PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM | Integrated Orbital Implants, Inc. | 1998-02-04 | 86 | 1 |
| K971583 | MEDPOR OCULAR SCREW AND ACCEOSSORIES | Porex Technologies Corp. | 1997-06-30 | 61 | 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