# K020409: Steamplus Sterilization Test

- Pathway: 510(k) (Traditional)
- Applicant: Spsmedical Supply Corp.
- Decided: Jul 18, 2002 after 161 days
- Product code: JOJ (Indicator, Physical/Chemical Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- 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: 1 generation back to K991276 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991276: Pass/Fail Challenge Pack, Propper Mfg. Co., Inc. (1999) Summary page 1.

## Recalls of this device
- May 25, 2022 · Class III · Z-1792-2022: 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
The SPSmedical STEAMPlus Sterilizer Test Pack is indicated for use in routine and challenge testing of steam sterilization cycles in both gravity displacement and prevacuum steam sterilizers.

Source page: https://510kreport.com/device/K020409
Methodology: https://510kreport.com/methodology