# K080420: Resert  XL HLD High Level Disinfectant

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Sep 2, 2008 after 200 days
- Product code: MED (Sterilant, Medical Devices)
- Device class: 2
- Regulation: 21 CFR 880.6885
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K924334 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970230: Sporox, Reckitt Benckiser, Inc. (1997) Summary page 2.

## Most influential descendants
- K091022: Modification to Resert XL HLD High Level Disinfectant (2010), 0 descendants of its own

## Recalls of this device
- May 25, 2022 · Class II · Z-1605-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

## Indications for use
Resert XL HLD is a ready to use liquid chemical germicide. The product is a 2.0% nominal hydrogen peroxide solution. The minimum recommended concentration (MRC) is 1.5%. Resert XL HLD is intended to be used by health care practitioners in clinical settings as a ready to use liquid chemical disinfectant for the high level disinfection of semi-critical medical devices for which alternative methods of terminal reprocessing are not suitable or available. High Level Disinfectant: Resert XL HLD High Level Disinfectant is a high level disinfectant when used or reused undiluted for a maximum of 21 days at a minimum temperature of 20°C (68°F) for a minimum immersion time of 8 minutes.

Source page: https://510kreport.com/device/K080420
Methodology: https://510kreport.com/methodology