# FRG: Wrap, Sterilization

- Device class: 2; regulation: 21 CFR 880.6850; FDA's rule: 510(k) required
- FDA decisions: 323
- 510(k) review time 2021–2025: median 201 days (middle half 93–261)
- Recalls: 47 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 9
- 2018: 5
- 2019: 9
- 2020: 5
- 2021: 4
- 2022: 9
- 2023: 9
- 2024: 11
- 2025: 9
- 2026: 4

## Most-cited predicates
- K082177: Kimguard One-Step Sterilization Wrap (2009), cited by 9
- K993535: Metapak Multi-Purpose Instrument Tray (2001), cited by 8
- K092167: Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500, KC600 (2009), cited by 7
- K871202: Flashpak Container System (1987), cited by 5
- K102158: Sigma Sterilization Pouch & Roll (2011), cited by 5
- K013003: Aptimax Instrument Tray, Instrument Mat and Instrument Holder (2002), cited by 5
- K053389: Aesculap Sterilcontainer System (2006), cited by 4
- K180672: Sterilization Pouch/Roll Made with Tyvek (2018), cited by 4
- K112805: Kimguard One-Step Sterilization Wrap (2012), cited by 4
- K091685: Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC 500, KC600 (2009), cited by 4

Source page: https://510kreport.com/product-code/FRG
Data by year (CSV): https://510kreport.com/product-code/FRG.csv