# K960777: MDT Unispore and Spor-Test Biologicalindicator

- Pathway: 510(k) (Traditional)
- Applicant: Mdt Corp., Inc.
- Decided: May 23, 1996 after 87 days
- Product code: FRC (Indicator, Biological Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K792649 (1980). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K792649: Unispore-Biological Indicators, Castle Co. (1980) Summary page 2.
- K800482: Stearothermohilus Spore Strips, Mdt Corp., Inc. (1980) Summary page 2.
- K801980: Spor-Test Culture Media, Mdt Corp., Inc. (1980) Summary page 2.

## Cited in the summary but kept off the family tree
- K801152: Unispore® biological indicators. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Most influential descendants
- K020205: Castle Peracetic Acid Biological Indicator Kit (2002), 3 descendants of its own
- K043135: Spsmedical Sporview PA Culture Set (2005), 1 descendant of its own
- K081879: Spsmedical Sporview PA Culture Set (2008), 0 descendants of its own
- K050664: Spor-Test PA Biological Indicator Kit (2005), 0 descendants of its own

## Indications for use
The MDT Biologic Company Unispore® and Spor-Test® Biological Indicators are intended to be used for the monitoring of sterilization processes in health care facilities. A biological indicator is a calibrated population of bacterial spores (of high resistance to the sterilization process monitored) on or in a carrier, put up in a package which maintains the integrity of the inoculated carrier and which is of convenience to the ultimate user, that serves to demonstrate whether sterilization conditions are met.

Source page: https://510kreport.com/device/K960777
Methodology: https://510kreport.com/methodology