# Andersen Sterilizers, Inc.

- Location (FDA's records): Haw River, NC
- FDA decisions: 19 (2015–2022): 19 510(k) clearances
- Product codes: FRG (6), JOJ (5), FRC (5), FLF (3)
- 510(k) review time since 2016: median 261 days, against 150 for FDA's reviews in the same codes and years (1 of 11 faster)
- Predicates its devices cite: 17 (12 its own); citations of its devices by later devices: 13 (12 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
- 3M Company: 1 (https://510kreport.com/company/3m)
- Arjo Wiggins Medical, Inc.: 1 (https://510kreport.com/company/arjo-wiggins-medical)
- Kenpak Converters, Inc.: 1 (https://510kreport.com/company/kenpak-converters)
- Albert Browne, Ltd.: 1 (https://510kreport.com/company/albert-browne)
- Sgm Biomedical, Inc.: 1 (https://510kreport.com/company/sgm-biomedical)

## Firms that cite its devices most
- Dukal Corp.: 1 (https://510kreport.com/company/dukal)

## Its most-cited devices
- K151585: Andersen EOGas 4 SteriTest (2015), cited by 3
- K150646: EOGas 4 Ethylene Oxide Gas Sterilizer (2015), cited by 2
- K152291: Sterisheet Sterilization Wrap (2015), cited by 2
- K152058: Tyvek Sterilization Pouches with Chevron Seal (2015), cited by 2
- K150645: AN1087 Dosimeter (2015), cited by 2
- K200335: Sterisheet Sterilization Wrap (2020), cited by 1

## Recent decisions
- K213296: Anprolene SteriTest RRBI (Apr 12, 2022)
- K202879: EOGas 4 Endo-SteriTest RRBI (Mar 3, 2021)
- K200335: Sterisheet Sterilization Wrap (Nov 12, 2020)
- K192978: EOGas 4 Ethylene Oxide Gas Sterilizer (Nov 12, 2020)
- K192980: EOGas 4 Endo-SteriTest (Nov 12, 2020)
- K200334: AN1036 Dosimeter (Nov 12, 2020)
- K200336: Tyvek Sterilization Pouches with Chevron Seal (Nov 12, 2020)
- K170439: AN87 Dosimeter (Nov 1, 2017)

Source page: https://510kreport.com/company/andersen-sterilizers