# K905425: Sporview

- Pathway: 510(k) (Traditional)
- Applicant: Spsmedical Supply Corp.
- Decided: Mar 27, 1992 after 479 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- 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.
4 later devices descend from it; 4 cite it directly.
0 of 5 devices 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.

## Most influential descendants
- K023716: Spsmedical Sporview Bacterial Spore Strip (2002), 1 descendant of its own
- K041099: Modification to Spsmedical Sporview Bacterial Spore Strip (2004), 0 descendants of its own
- K971432: Prospore (1997), 0 descendants of its own
- K962441: Prospore (Stearo for Steam Sterilizer) (1996), 0 descendants of its own

## Recalls of this device
- Dec 11, 2024 · Class II · Z-1141-2025: Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the
- May 25, 2022 · Class III · Z-1790-2022: 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.

Source page: https://510kreport.com/device/K905425
Methodology: https://510kreport.com/methodology