# K931052: Metricide 28

- Pathway: 510(k) (Traditional)
- Applicant: Metrex Research Corp.
- Decided: Dec 6, 1994 after 658 days
- Product code: MED (Sterilant, Medical Devices)
- Device class: 2
- Regulation: 21 CFR 880.6885
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- May 25, 2022 · Class II · Z-1614-2022: 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.
- Jul 13, 2018 · Class II · Z-1721-2019: Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes.

Source page: https://510kreport.com/device/K931052
Methodology: https://510kreport.com/methodology