Data / Medical devices / United Kingdom / Albert Browne Ltd.
Albert Browne Ltd.: FDA-registered device maker in Leicester, United Kingdom, 28 510(k) clearances
Albert Browne Ltd. is registered with the FDA (registration 8021896) in Leicester, United Kingdom. It lists 11 device types. The FDA files 28 510(k) clearances under its listings, the newest dated October 2, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8021896
- FEI number
- 3001168737
- Address
- Rayns Way Watermead Business Park Syston, Leicester, United Kingdom, LE7 1PF
- Owner or operator
- STERIS Corporation (10078069)
- Roles
- Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- October 9, 2020
- Registered through
- 2027
- Brand names listed
- 1 Level General Purpose Rack (CM53) (QB-MF), 2 Level Manifold Rack (FD74800) (QB-MF), 2 Level Manifold Rack with Equal Level Space (FD79100) (QB-MF), 2 Level Manifold Rack with Equal Level Space - Large (FD81000) (QB-MF), 2-Level Instrument Rack for Reliance 333 (MB000015) (QB-CFE), 3 Level MIS Rack with Removable Upper Insert - Large (FD81600) (QB-MF), 3 Level Manifold Rack (FD009) (QB-MF), 3 Level Manifold Rack (FD74900) (QB-MF) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| A Chemical Vapor Sterilization Multivariable Chemical Indicator | QKM | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Exporter to the US | accessdata.fda.gov |
| Accessories, Cleaning, For Endoscope | FEB | 2 | Repackager or relabeler | accessdata.fda.gov |
| Cleaner, Ultrasonic, Medical Instrument | FLG | 1 | Manufacturer | accessdata.fda.gov |
| Disinfector, Medical Devices | MEC | 2 | Manufacturer | accessdata.fda.gov |
| Headrest, Neurosurgical | HBM | 1 | Exporter to the US | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Operating Room Accessories Table Tray | FWZ | 1 | Exporter to the US | accessdata.fda.gov |
| Table And Attachments, Operating-Room | BWN | 1 | Exporter to the US | accessdata.fda.gov |
| Table, Operating-Room, Ac-Powered | FQO | 1 | Exporter to the US | accessdata.fda.gov |
| Table, Operating-Room, Electrical | GDC | 1 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 2, 2026 | K261791 | MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor | FEB | Substantially Equivalent | Steris | accessdata.fda.gov |
| December 4, 2024 | K243475 | Chemical Indicator for enspire CLCSPS (LCC015) | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| June 11, 2024 | K241344 | MetriCide OPA Plus Solution Test Strip | JOJ | Substantially Equivalent | Steris | accessdata.fda.gov |
| April 17, 2024 | K240032 | Celerity Chemical Indicator for enspire 3000 CLCSPS | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| December 8, 2023 | K233654 | VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems | JOJ | Substantially Equivalent | Steris | accessdata.fda.gov |
| October 27, 2023 | K233187 | Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) | JOJ | Substantially Equivalent | Steris | accessdata.fda.gov |
| August 7, 2023 | K231488 | Celerity HP Chemical Indicator; Celerity HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape | JOJ | Substantially Equivalent | Steris | accessdata.fda.gov |
| July 17, 2023 | K230558 | Revital-Ox PAA High Level Disinfectant Chemical Indicator | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| January 7, 2022 | K213262 | CELERITY HP Chemical Indicator | QKM | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 5, 2019 | K192020 | Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| December 10, 2018 | K182724 | CelerityTM 10 STEAM Chemical Indicator | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| March 2, 2018 | K173428 | VERIFY Chemical Indicator for S40 Sterilant | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| February 9, 2018 | K172746 | VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| March 21, 2017 | K162758 | VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| April 14, 2015 | K143333 | Revital-Ox RESERT Solution Test Strip | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| July 17, 2014 | K140515 | VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| March 10, 2011 | K103053 | VERIFY 270FP CHALLENGE PACK | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| November 22, 2010 | K102217 | SYSTEM 1E CHEMICAL INDICATOR | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| January 25, 2008 | K073683 | VERIFY CHALLENGE PACKS - VERSION 2 | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| November 14, 2007 | K071895 | VERIFY 275 DEGREE F. 3-10 INDICATOR; 10 INDICATOR; 3 INDICATOR | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| September 5, 2007 | K070895 | VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK; 275F 3 CHALLENGE PACK; 275F 10 CHALLENGE PACK | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| July 17, 2007 | K070461 | VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4 | JOJ | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| January 12, 2007 | K063285 | RELIANCE CI PROCESS INDICATOR | JOJ | Substantially Equivalent | Albert Browne , Ltd. | accessdata.fda.gov |
| August 25, 2006 | K061738 | ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD | JOJ | Substantially Equivalent | Albert Browne , Ltd. | accessdata.fda.gov |
| March 7, 2006 | K060103 | ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS | JOJ | Substantially Equivalent | Albert Browne , Ltd. | accessdata.fda.gov |
| July 3, 2002 | K002741 | BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK | JOJ | Substantially Equivalent | Albert Browne , Ltd. | accessdata.fda.gov |
| October 1, 2001 | K012335 | BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS | JOJ | Substantially Equivalent | Albert Browne , Ltd. | accessdata.fda.gov |
| June 2, 1994 | K922481 | BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE | JOJ | Substantially Equivalent | Board of Directors, Albert Browne , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 25, 2003 | 25811 | Not yet classified | Terminated | Gluteraldehyde Concentration Indicators. MetriTest 1.5% and MetriTest 1.8%, also OmniChek 1.5% and OmniCheck 1.8% | Moisture ingress into packaging of test strips may cause premature failure. | accessdata.fda.gov |
Compare with other makers
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of Table, Operating-Room, Ac-Powered
- All makers of Accessories, Cleaning, For Endoscope
- All makers of Table And Attachments, Operating-Room
- All makers of Disinfector, Medical Devices
- All makers of Headrest, Neurosurgical
Updated October 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.