Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Integrated Orbital Implants, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
105 daysmedian FDA review time
174 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003338 | BIO-EYE II ORBITAL IMPLANT | Integrated Orbital Implants, Inc. | 2001-02-07 | 105 | 1 |
| K000151 | PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE | Integrated Orbital Implants, Inc. | 2000-04-10 | 82 | 0 |
| K982562 | BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER | Integrated Orbital Implants, Inc. | 1998-12-28 | 158 | 2 |
| K974203 | PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM | Integrated Orbital Implants, Inc. | 1998-02-04 | 86 | 1 |
| K891137 | MOTILITY ORBITAL IMPLANT | Integrated Orbital Implants, Inc. | 1989-08-24 | 174 | 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