Atlas FDA

LRJ

73 FDA 510(k) clearances · Product code

80 daysmedian time to decision
574 days90th percentile
73clearances measured

FDA profile

Official device name
Disinfectant, Medical Devices
Device class
Class I (low risk)
Regulation
21 CFR 880.6890
Medical specialty
General Hospital
Adverse events (MAUDE)
2021: 497 · 2022: 171 · 2023: 95 · 2024: 116 · 2025: 70 · 2026: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
CONTROL III ELITE (K992661)Maril Products, Inc.1999-09-14
PRO-PORTION CLEANER/DISINFECTANT (K991509)Sultan Chemists, Inc.1999-07-14
MICROSTAT 2 (K984485)Chemlink Laboratories, LLC1999-01-13
AMERSE 2 (K983947)STERIS Corporation1998-12-04
DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH (K983869)Caltech Industries, Inc.1998-11-30
LOW PH PHENOLIC 256 (K983585)Central Solutions, Inc.1998-11-06
CITREX HOSPITAL SPRAY DISINFECTANT (K982985)Caltech Industries, Inc.1998-11-02
KLEENASEPTIC (K981023)Metrex Research Corp.1998-04-30
T.B.Q. RTU (K980369)STERIS Corporation1998-02-17
GERMICIDAL CLOTH (K974304)Convatec, A Division of E.R. Squibb & Sons1998-01-13
NOVIGUARD QUICK DRY (K961044)Dr. Novis Smith & Co., Inc.1997-07-03
BLUE CHIP GERMICIDAL CLEANER & DEODORANT (K970825)S.C. Johnson Professional1997-03-14
CIDE-SWIPES P-100B & CIDE-SWIPES C-100A (K964376)Mp Scientific, Inc.1996-12-23
VIREX II 128 GERMICIDAL CLEANER AND DEODORANT (K964828)S.C. Johnson & Son, Inc.1996-12-19
COVERAGE SPRAY HBV (K964835)Convatec, A Division of E.R. Squibb & Sons1996-12-16
VIREX TB READY-TO-USE DSINFECTANT CLEANER & DEODORANT (K964535)S.C. Johnson & Son, Inc.1996-12-13
VIREX II 256 GERMICIDAL CLEANER AND DEODORANT (K964613)S.C. Johnson & Son, Inc.1996-12-13
COVERAGE HBV (K964749)Convatec, A Division of E.R. Squibb & Sons1996-12-13
TRIAD II DISINFECTANT CLEANER AND DEODORANT (K964610)S.C. Johnson & Son, Inc.1996-12-13
LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46) (K963353)Reckitt Benckiser, Inc.1996-10-18
T.B.Q. (K962739)Convatec, A Division of E.R. Squibb & Sons1996-10-07
DMS-9000 (K960836)O.R. Solutions, Inc.1996-09-12
BEAUCOUP GENERAL PURPOSE DISINFECTANT (K960580)Huntington Laboratories, Inc.1996-03-12
ASCEND GENERAL PURPOSE DISINFECTANT (K960582)Huntington Laboratories, Inc.1996-03-12
MATAR GENERAL PURPOSE DISINFECTANT (K960583)Huntington Laboratories, Inc.1996-03-12
PRO-TECH (K955850)Central Solutions, Inc.1996-02-09
KLORMAN (K923693)Matrix Medica, Inc.1996-01-23
VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT (K934014)Biotrol, USA, Inc.1995-12-06
BIOCIDE CLEANER/DISINFECTANT (K934150)Juan Sierra1995-12-06
LD GENERAL PURPOSE DISINFECTANT (K952929)Alcide Corp.1995-10-07
EXSPOR (K953241)Alcide Corp.1995-09-29
Q5. 5-5.5NPB-2.5HW (K954292)Central Solutions, Inc.1995-09-27
CITRACE HOSPITAL GERMICIDAL DEODORIZER (K952405)Caltech Industries, Inc.1995-08-28
TRI-CEN GERMICIDAL DETERGENT (K951020)Central Solutions, Inc.1995-08-28
DISPATCH HOSPITAL CLEANER DISINFECTANT WITH BLEACH (K952336)Caltech Industries, Inc.1995-08-28
FORMULATION HWS-64 EPA REG. NO. 47371-131 (K953011)Huntington Laboratories, Inc.1995-08-11
FORMULATION HWS-256 EPA REG. NO. 47371-129 (K953010)Huntington Laboratories, Inc.1995-08-11
FORMULATION HWS-128 EPA REG. NO. 47371-130 (K953009)Huntington Laboratories, Inc.1995-08-11
PRECISE HOSPITAL FOAM CLEANER DISINFECTANT (K951512)Caltech Industries, Inc.1995-08-07
AMUCHINA (K952302)Amuchina Intl., Inc.1995-07-26
PHENO-CEN GERMICIDAL DETERGENT (K951162)Central Solutions, Inc.1995-07-11
RENALIN COLD STERILANT (K941439)Minntech Corp.1995-06-26
IMNI-II (K951983)Cottrell, Ltd.1995-06-20
Q4.5-5.0PB-4.5 (K951342)Central Solutions, Inc.1995-04-25
CAVICIDE SURFACE DISINFECTANT/DECONTAMINANT CLEANER (K951123)Micro-Aseptic Products, Inc.1995-04-25
PHENO-CEN SPRAY DISINFECTANT DEODORANT (K951317)Central Solutions, Inc.1995-04-25
LYSOL I.C. BRAND DISINFECTANT (K940382)National Laboratories1995-04-21
HOSPITAL BROAD BAND CLEANDR - DISINFECTANT-DEODORANT (K946078)Clariant Corporation1995-03-24
OCIDE HOSPITAL CLEANER-DISINFECTANT (K945227)Clariant Corporation1995-03-23
COLDCIDE-2 (K950553)Metrex Research Corp.1995-03-22
COLDCIDE-10 (K950516)Metrex Research Corp.1995-03-22
LYSOL I.C. BRAND INSTRUMENT DISINFECTANT PRESOAK (K940383)National Laboratories1995-03-22
MULTI-WASH (K950324)Multi-Wash Medical, Ltd.1995-03-22
DIACIDE HD DISINFECTING SOLUTION (K944037)Gulfstream Medical1995-03-22
CONTROL III DISINFECTANT GERMICIDE (K944179)Maril Products, Inc.1995-03-22
LYSOL I.C. BRAND QUATERNARY CLEANER DISINFECTANT (K940381)National Laboratories1994-07-25
LYSOL I.C. BRAND DISINFECTANT SPRAY (K940400)L&F Products1994-07-25
AMERSE (K931477)Calgon Vestal Div.1994-06-17
VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM (K931816)Calgon Vestal Div.1994-05-26
LPH (K931342)Calgon Vestal Div.1994-05-26
VESPHENE II (K931573)Calgon Vestal Div.1994-05-16
LONZA FORMULATION R-82 (K932502)Lonza, Inc.1994-05-12
LONZA FORMULATION R-82 (K932277)Calgon Vestal Div.1994-05-12
CIDEX PLUS 28 DAY SOLUTION (K923744)Johnson & Johnson Medical, Inc.1994-03-29
CIDEX ACTIVATED DIALDEHYDE SOLUTION (K924434)Johnson & Johnson Medical, Inc.1994-03-29
SPORICIDIN BRAND DISINFECT TOWEL, SPRAY/SOLUT MODI (K926013)Sporicidin Intl.1993-02-12
SPORICIDIN BRAND DISINFECT TOWELETTES/SPRAY/SOLUT (K922262)Sporicidin Intl.1992-09-15
SPORICIDIN BRAND DISINFECTANT SOLUTION (K904581)Sporicidin Intl.1992-05-18
SPORICIDIN BRAND DISINFECTANT SPRAY (K904580)Sporicidin Intl.1992-05-18
SPORICIDIN BRAND DISINFECTANT TOWELETTES (K904579)Sporicidin Intl.1992-05-18
RENALIN COLD STERILANT (K882564)Minntech Corp.1989-01-09
HEATED INSTRUMENT BATH (K870276)Simpson/Basye, Inc.1987-05-07
CLEANING SOLUTION, CATALOG NO. 8203 (K870759)Treace Medical, Inc.1987-05-07

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