Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HPX — Predicate Candidate Screening
74 FDA 510(k) clearances under this product code; the 50 most recent screened below.
51 daysmedian FDA review time
181 days90th percentile
74clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955777 | PMMA CLASIC | Rand Scientific Corp. | 1996-05-16 | 148 | 0 |
| K940106 | KERATOPLASTY SUTURING LENS | Visionary Technologies of Miami, Inc. | 1994-05-25 | 135 | 0 |
| K913081 | MULTI-VIEW BIFOCALS | Camp Contact Lenses | 1991-10-23 | 107 | 0 |
| K897021 | MARTIN-HENSLEY SEGMENT LENS | Bruce W. Martin O.D. and Edward Hensley | 1990-06-22 | 185 | 0 |
| K895411 | OPTIKEM PMMA CONTACT LENS | Optikem Polymers, Inc. | 1990-02-27 | 174 | 0 |
| K874591 | ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY | Vitreo Dynamics, Co. | 1988-05-03 | 176 | 0 |
| K865111 | CHARTER HARD CONTACT LENS CLEANING SOLUTION | Paco Pharmaceutical Services, Inc. | 1987-01-20 | 20 | 0 |
| K864343 | BL1 (HARD CONTACT LENS) | Beta Labs, Inc. | 1986-11-28 | 24 | 0 |
| K863974 | CHARTER LABORATORIES INC. LENS LUBRICANT | Paco Pharmaceutical Services, Inc. | 1986-11-10 | 27 | 0 |
| K862952 | CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES | Paco Pharmaceutical Services, Inc. | 1986-09-25 | 51 | 0 |
| K862811 | AQUALUX LENS CASE | Safeway Products, Inc. | 1986-09-03 | 41 | 0 |
| K861643 | STYLEKEEPER CONTACT LENS CARRYING CASE | Allergan, Inc. | 1986-06-02 | 33 | 0 |
| K860677 | EASY EYES TM LENS CARRYING CASE | Applied Laboratories, Inc. | 1986-05-29 | 93 | 0 |
| K861712 | WETTING & SOAKING HARD CONTACT LENS SOLUTION | Maurry Biological Co. | 1986-05-29 | 24 | 0 |
| K861642 | LENSKEEPER CONTACT LENS CARRYING CASE | Allergan, Inc. | 1986-05-29 | 29 | 0 |
| K854968 | BAUSCH & LOMB LENS CARRYING CASE | Bausch & Lomb, Inc. | 1986-04-04 | 114 | 0 |
| K853809 | DAILY HARD CONTACT LENS CLEANER | Maurry Biological Co. | 1986-03-11 | 181 | 0 |
| K853808 | HARD CONTACT LENS CLEANING & SOAKING SOLUTION | Maurry Biological Co. | 1986-03-11 | 181 | 0 |
| K854442 | UVASORB-400 | Optatint, Inc. | 1986-02-19 | 106 | 0 |
| K853807 | ALL-IN-ONE HARD CONTACT LENS SOLUTION | Maurry Biological Co. | 1985-12-16 | 96 | 0 |
| K853811 | HARD CONTACT LENS SOAKING SOLUTION | Maurry Biological Co. | 1985-12-16 | 96 | 0 |
| K853810 | WETTING SOLUTION FOR HARD CONTACT LENSES | Maurry Biological Co. | 1985-12-16 | 96 | 0 |
| K853729 | KESTREL CONTACT LENS STORAGE CASE(POLYSTYRENE) | Ryder Intl. Corp. | 1985-12-13 | 98 | 0 |
| K853728 | KESTREL CONTACT LENS STORAGE CASE(NORYL) | Ryder Intl. Corp. | 1985-12-13 | 98 | 0 |
| K853870 | EASY EYES TM LENS CARRYING CASE | Applied Laboratories, Inc. | 1985-12-10 | 84 | 0 |
| K853445 | IN A WINK LUBRICATING & REWETTING DROPS | Ciba Vision Care | 1985-11-29 | 105 | 0 |
| K850909 | RHODA-LUX LENS BLANKS | Optatint, Inc. | 1985-10-04 | 213 | 0 |
| K852384 | SIGHT SAVER ALL PURPOSE LENS CARRYING CASE | Bausch & Lomb, Inc. | 1985-07-31 | 56 | 0 |
| K851887 | ON TARGET | Newman Assoc. | 1985-05-30 | 29 | 0 |
| K851497 | MARLIN CONTACT LENS CASE | Marlin Industries | 1985-05-16 | 31 | 0 |
| K850046 | PROFESSIONAL SUPPLIES, INC.LENS CARRYING CASE | Professional Supplies, Inc. | 1985-04-15 | 98 | 0 |
| K841881 | EASY EYES TM LENS CARRYING CASE | Eaton Medical Corp. | 1984-12-03 | 210 | 0 |
| K843342 | LENSKEEPER LENS CARRYING CASE | Allergan Pharmaceuticals, Inc. | 1984-11-19 | 84 | 0 |
| K833903 | BENZETHONIUM CHLORIDE | Blairex Laboratories, Inc. | 1984-05-30 | 198 | 0 |
| K831973 | HARD CONTACT LENS CASE | Moonbeam International, Inc. | 1983-10-19 | 121 | 0 |
| K832706 | SENSITIVE EYES | Bausch & Lomb, Inc. | 1983-10-04 | 53 | 0 |
| K832810 | HARD CONTACT LENS CLEANER | Blairex Laboratories, Inc. | 1983-09-29 | 42 | 0 |
| K830740 | CLERZ LUBRICATING & REWETTING EYE DROPS | CooperVision, Inc. | 1983-06-02 | 86 | 0 |
| K823528 | GLISLENS | Bio-Products, Inc. | 1982-12-22 | 22 | 0 |
| K822315 | GFB-B CONTACT LENS BLANKS | Hamel, Park, Mccabe & Saunders | 1982-11-16 | 105 | 0 |
| K822706 | PRE-SERT | Allergan, Inc. | 1982-10-22 | 45 | 0 |
| K822707 | CLEAN-N-SOAK | Allergan, Inc. | 1982-10-18 | 41 | 0 |
| K822495 | LE CASE HARD CONTACT LENS STORAGE CASE | Optikem International, Inc. | 1982-09-30 | 43 | 0 |
| K821866 | OXY-PMMA | Petrarch Systems & Professional Pharm | 1982-09-14 | 82 | 0 |
| K822105 | LENS EASY ON | L.E.O. Corp. | 1982-08-20 | 31 | 0 |
| K821054 | TOTAL | Allergan, Inc. | 1982-05-13 | 28 | 0 |
| K821052 | SOAKARE | Allergan, Inc. | 1982-05-13 | 28 | 0 |
| K821051 | LIQUIFILM WETTING SOLUTION | Allergan, Inc. | 1982-05-13 | 28 | 0 |
| K821055 | BLINK-N-CLEAN | Allergan, Inc. | 1982-05-10 | 25 | 0 |
| K820817 | OPTACRY/95 GRAY CONTACT LENS BLANKS | Optacryl, Inc. | 1982-05-05 | 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