Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
HQX — Predicate Candidate Screening
16 FDA 510(k) clearances under this product code; the 50 most recent screened below.
77 daysmedian FDA review time
199 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023481 | MICROVISION SCLERAL BUCKLING COMPONENTS | Microvision, Inc. | 2003-01-08 | 83 | 0 |
| K983581 | OCU-GUARD AND OCU-GUARD SUPPLE | Bio-Vascular, Inc. | 1998-11-06 | 24 | 0 |
| K980816 | RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) | Fci Ophthalmics, Inc. | 1998-09-18 | 199 | 0 |
| K963219 | RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, | Fci Ophthalmics, Inc. | 1996-10-28 | 73 | 0 |
| K950806 | SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS | Mira, Inc. | 1996-06-05 | 469 | 0 |
| K950599 | STORS SCLERAL SPONGE II (LINCOFF DESIGN) | Storz Ophthalmics, Inc. | 1995-03-02 | 21 | 0 |
| K945172 | VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS | Visitec Co. | 1995-01-17 | 88 | 0 |
| K902308 | TAMCENAN OCULAR EXPLANTS AND BANDS | Tamcenan Corp. | 1990-06-19 | 28 | 0 |
| K901002 | O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES | Oculo Plastik, Inc. | 1990-05-22 | 81 | 0 |
| K900929 | PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL | Oculo Plastik, Inc. | 1990-05-18 | 80 | 0 |
| K900928 | COX MALAR EMINENCE IMPLANTS | Oculo Plastik, Inc. | 1990-05-15 | 77 | 0 |
| K900927 | CODERE-DURETTE ORBITAL FLOOR IMPLANT | Oculo Plastik, Inc. | 1990-05-15 | 77 | 0 |
| K900930 | SPIVEY-ALLEN ORBITAL FLOOR IMPLANT | Oculo Plastik, Inc. | 1990-05-15 | 77 | 0 |
| K863946 | POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT | Porex Medical | 1987-02-27 | 140 | 0 |
| K832481 | SCLERAL BUCKLING IMPLANTS DIF/TYPES | Storz Instrument Co. | 1983-09-20 | 56 | 0 |
| K800140 | SILASTIC SCLERAL SPONGE II W/CIRCLING BD | Dow Corning Corp. Healthcare Industries Materials | 1980-03-03 | 42 | 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