# K961721: Steritec Disposable Biological Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: Steritec Products Mfg Co, Inc.
- Decided: Aug 23, 1996 after 112 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
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. The FDA summary names its predicate without a number.
- (no number) AAMI standard biological test pack: named in the summary without a submission number

## Indications for use
The SteriTec Disposable Biological Test Puck is a stcam sierilization monitor designed specifically for biological testing of 121"C (2507F) gravity or 132°C (270°F) pre-vacuum steam sterilizers. The pack cuonsisls ol a self-contairied biological indicator containing B. stearothermophilus spurcs inside a stall package of porous and nonporous materials.

Source page: https://510kreport.com/device/K961721
Methodology: https://510kreport.com/methodology