# Sterilucent, Inc.

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 7 (2014–2019): 7 510(k) clearances
- Product codes: FRC (3), MLR (2), KCT (1), JOJ (1)
- 510(k) review time since 2016: median 88 days, against 88 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 10 (2 its own); citations of its devices by later devices: 4 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- STERIS Corporation: 2 (https://510kreport.com/company/steris)
- Mesa Laboratories, Inc.: 2 (https://510kreport.com/company/mesa-laboratories)
- Advanced Sterilization Products: 1 (https://510kreport.com/company/advanced-sterilization-products)
- Carefusion 2200, Inc.: 1 (https://510kreport.com/company/carefusion-2200)
- Crosstex International: 1 (https://510kreport.com/company/crosstex-international)
- Spsmedical Supply Corp.: 1 (https://510kreport.com/company/spsmedical-supply)

## Firms that cite its devices most
- 3M Company: 1 (https://510kreport.com/company/3m)
- Plasmapp Co,., Ltd.: 1 (https://510kreport.com/company/plasmapp)

## Its most-cited devices
- K140464: Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (2014), cited by 2
- K141312: Sterilucent Process Challenge Device (2014), cited by 1
- K192001: Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device (2019), cited by 1

## Recent decisions
- K192001: Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device (Oct 22, 2019)
- K191999: Sterilucent VH2O2 Chemical Indicators (Oct 21, 2019)
- K190005: Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (Sep 13, 2019)
- K142109: Sterilucent Sterilization Container System (Jan 20, 2015)
- K141238: Sterilucent Self-Contained Biological Indicator (Nov 3, 2014)
- K141312: Sterilucent Process Challenge Device (Oct 31, 2014)
- K140464: Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (Oct 31, 2014)

Source page: https://510kreport.com/company/sterilucent