Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LRJ — Predicate Candidate Screening
73 FDA 510(k) clearances under this product code; the 50 most recent screened below.
80 daysmedian FDA review time
574 days90th percentile
73clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992661 | CONTROL III ELITE | Maril Products, Inc. | 1999-09-14 | 36 | 0 |
| K991509 | PRO-PORTION CLEANER/DISINFECTANT | Sultan Chemists, Inc. | 1999-07-14 | 75 | 0 |
| K984485 | MICROSTAT 2 | Chemlink Laboratories, LLC | 1999-01-13 | 27 | 0 |
| K983947 | AMERSE 2 | STERIS Corporation | 1998-12-04 | 29 | 0 |
| K983869 | DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH | Caltech Industries, Inc. | 1998-11-30 | 28 | 0 |
| K983585 | LOW PH PHENOLIC 256 | Central Solutions, Inc. | 1998-11-06 | 24 | 0 |
| K982985 | CITREX HOSPITAL SPRAY DISINFECTANT | Caltech Industries, Inc. | 1998-11-02 | 68 | 0 |
| K981023 | KLEENASEPTIC | Metrex Research Corp. | 1998-04-30 | 42 | 0 |
| K980369 | T.B.Q. RTU | STERIS Corporation | 1998-02-17 | 18 | 0 |
| K974304 | GERMICIDAL CLOTH | Convatec, A Division of E.R. Squibb & Sons | 1998-01-13 | 57 | 0 |
| K961044 | NOVIGUARD QUICK DRY | Dr. Novis Smith & Co., Inc. | 1997-07-03 | 476 | 0 |
| K970825 | BLUE CHIP GERMICIDAL CLEANER & DEODORANT | S.C. Johnson Professional | 1997-03-14 | 8 | 0 |
| K964376 | CIDE-SWIPES P-100B & CIDE-SWIPES C-100A | Mp Scientific, Inc. | 1996-12-23 | 52 | 0 |
| K964828 | VIREX II 128 GERMICIDAL CLEANER AND DEODORANT | S.C. Johnson & Son, Inc. | 1996-12-19 | 17 | 0 |
| K964835 | COVERAGE SPRAY HBV | Convatec, A Division of E.R. Squibb & Sons | 1996-12-16 | 21 | 0 |
| K964535 | VIREX TB READY-TO-USE DSINFECTANT CLEANER & DEODORANT | S.C. Johnson & Son, Inc. | 1996-12-13 | 31 | 0 |
| K964613 | VIREX II 256 GERMICIDAL CLEANER AND DEODORANT | S.C. Johnson & Son, Inc. | 1996-12-13 | 25 | 0 |
| K964749 | COVERAGE HBV | Convatec, A Division of E.R. Squibb & Sons | 1996-12-13 | 17 | 0 |
| K964610 | TRIAD II DISINFECTANT CLEANER AND DEODORANT | S.C. Johnson & Son, Inc. | 1996-12-13 | 25 | 0 |
| K963353 | LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. | Reckitt Benckiser, Inc. | 1996-10-18 | 53 | 0 |
| K962739 | T.B.Q. | Convatec, A Division of E.R. Squibb & Sons | 1996-10-07 | 84 | 0 |
| K960836 | DMS-9000 | O.R. Solutions, Inc. | 1996-09-12 | 196 | 0 |
| K960580 | BEAUCOUP GENERAL PURPOSE DISINFECTANT | Huntington Laboratories, Inc. | 1996-03-12 | 29 | 0 |
| K960582 | ASCEND GENERAL PURPOSE DISINFECTANT | Huntington Laboratories, Inc. | 1996-03-12 | 29 | 0 |
| K960583 | MATAR GENERAL PURPOSE DISINFECTANT | Huntington Laboratories, Inc. | 1996-03-12 | 29 | 0 |
| K955850 | PRO-TECH | Central Solutions, Inc. | 1996-02-09 | 44 | 0 |
| K923693 | KLORMAN | Matrix Medica, Inc. | 1996-01-23 | 1279 | 0 |
| K934014 | VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT | Biotrol, USA, Inc. | 1995-12-06 | 841 | 0 |
| K934150 | BIOCIDE CLEANER/DISINFECTANT | Juan Sierra | 1995-12-06 | 833 | 0 |
| K952929 | LD GENERAL PURPOSE DISINFECTANT | Alcide Corp. | 1995-10-07 | 110 | 0 |
| K953241 | EXSPOR | Alcide Corp. | 1995-09-29 | 80 | 0 |
| K954292 | Q5. 5-5.5NPB-2.5HW | Central Solutions, Inc. | 1995-09-27 | 13 | 0 |
| K952405 | CITRACE HOSPITAL GERMICIDAL DEODORIZER | Caltech Industries, Inc. | 1995-08-28 | 98 | 0 |
| K951020 | TRI-CEN GERMICIDAL DETERGENT | Central Solutions, Inc. | 1995-08-28 | 174 | 0 |
| K952336 | DISPATCH HOSPITAL CLEANER DISINFECTANT WITH BLEACH | Caltech Industries, Inc. | 1995-08-28 | 102 | 0 |
| K953011 | FORMULATION HWS-64 EPA REG. NO. 47371-131 | Huntington Laboratories, Inc. | 1995-08-11 | 44 | 0 |
| K953010 | FORMULATION HWS-256 EPA REG. NO. 47371-129 | Huntington Laboratories, Inc. | 1995-08-11 | 44 | 0 |
| K953009 | FORMULATION HWS-128 EPA REG. NO. 47371-130 | Huntington Laboratories, Inc. | 1995-08-11 | 44 | 0 |
| K951512 | PRECISE HOSPITAL FOAM CLEANER DISINFECTANT | Caltech Industries, Inc. | 1995-08-07 | 126 | 0 |
| K952302 | AMUCHINA | Amuchina Intl., Inc. | 1995-07-26 | 71 | 0 |
| K951162 | PHENO-CEN GERMICIDAL DETERGENT | Central Solutions, Inc. | 1995-07-11 | 119 | 0 |
| K941439 | RENALIN COLD STERILANT | Minntech Corp. | 1995-06-26 | 459 | 0 |
| K951983 | IMNI-II | Cottrell, Ltd. | 1995-06-20 | 54 | 0 |
| K951342 | Q4.5-5.0PB-4.5 | Central Solutions, Inc. | 1995-04-25 | 33 | 0 |
| K951123 | CAVICIDE SURFACE DISINFECTANT/DECONTAMINANT CLEANER | Micro-Aseptic Products, Inc. | 1995-04-25 | 60 | 1 |
| K951317 | PHENO-CEN SPRAY DISINFECTANT DEODORANT | Central Solutions, Inc. | 1995-04-25 | 33 | 0 |
| K940382 | LYSOL I.C. BRAND DISINFECTANT | National Laboratories | 1995-04-21 | 450 | 0 |
| K946078 | HOSPITAL BROAD BAND CLEANDR - DISINFECTANT-DEODORANT | Clariant Corporation | 1995-03-24 | 101 | 0 |
| K945227 | OCIDE HOSPITAL CLEANER-DISINFECTANT | Clariant Corporation | 1995-03-23 | 148 | 0 |
| K950553 | COLDCIDE-2 | Metrex Research Corp. | 1995-03-22 | 43 | 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