# Sigma Medical Supplies Corp.

- Location (FDA's records): New Taipei City, TW
- FDA decisions: 5 (2011–2021): 5 510(k) clearances
- Names in FDA's records: Sigma Medical Supplies Corp. (3); Sigma Medical Supplies Corporation (2)
- Product codes: FRG (5)
- 510(k) review time since 2016: median 84 days, against 150 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 6 (3 its own); citations of its devices by later devices: 12 (3 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
- A.R. Medicom, Inc.: 1 (https://510kreport.com/company/ar-medicom)
- Winner Medical (Usa), Inc.: 1 (https://510kreport.com/company/winner-medical-usa)
- Advanced Sterilization Products: 1 (https://510kreport.com/company/advanced-sterilization-products)

## Firms that cite its devices most
- Wipak OY: 2 (https://510kreport.com/company/wipak)
- Sterileright Packaging Mfg., Inc.: 1 (https://510kreport.com/company/sterileright-packaging-mfg)
- Yichang Xinxin Paper Products Co., Ltd.: 1 (https://510kreport.com/company/yichang-xinxin-paper-products)
- Pms Tibbi Cihazlar Teknolojisi San VE Tic AS: 1 (https://510kreport.com/company/pms-tibbi-cihazlar-teknolojisi-san-ve-tic)
- U&U Medical Technology Co, Ltd.: 1 (https://510kreport.com/company/u-u-medical-technology)
- Plasmapp Co,., Ltd.: 1 (https://510kreport.com/company/plasmapp)
- Pms Tip Teknolojileri Sanayi VE Ticaret Limited Std: 1 (https://510kreport.com/company/pms-tip-teknolojileri-sanayi-ve-ticaret-std)
- Km Corporation: 1 (https://510kreport.com/company/km)

## Its most-cited devices
- K102158: Sigma Sterilization Pouch & Roll (2011), cited by 5
- K180672: Sterilization Pouch/Roll Made with Tyvek (2018), cited by 4
- K180661: SIGMA Sterilization Pouch and Roll (2018), cited by 2
- K133838: Sterilization Pouch/Roll Made with Tyvek (2015), cited by 1

## Recent decisions
- K202462: SIGMA Sterilization Pouch and Roll (Apr 23, 2021)
- K180672: Sterilization Pouch/Roll Made with Tyvek (Jun 6, 2018)
- K180661: SIGMA Sterilization Pouch and Roll (Jun 5, 2018)
- K133838: Sterilization Pouch/Roll Made with Tyvek (Mar 11, 2015)
- K102158: Sigma Sterilization Pouch & Roll (Aug 2, 2011)

Source page: https://510kreport.com/company/sigma-medical-supplies