# K082620: Once-a-Day Vertos Test Pack

- Pathway: 510(k) (Abbreviated)
- Applicant: Propper Mfg. Co., Inc.
- Decided: Jul 8, 2009 after 302 days
- Product code: JOJ (Indicator, Physical/Chemical 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 K961156 (1997). 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)
- K961156: Once-a-Day  Bowie and Dick Test Pack., Propper Mfg. Co., Inc. (1997) Summary page 1.

## Indications for use
The Once-A-Day® VertosTM Test Pack is an air removal indicator that is intended to be used by a health care provider as a standardized test pack, e.g., Bowie Dick Test Pack, to assess the ability of a pre-vacuum sterilizer to remove air and allow steam to penetrate into wrapped goods and porous loads operating at 1340 C using a 3.5 minutes exposure. time. The Once-A-Day® VertosTM Test Pack is directed to be positioned on the lowest shelf over the chamber drain in an otherwise empty chamber. An unexposed test pattern is uniformly blue and a uniform pink test pattern represents an acceptable cycle. The Once-A-Day® VertosTM Test Pack is noI an indication that the sterilizer has reached the parameters for sterilization.

Source page: https://510kreport.com/device/K082620
Methodology: https://510kreport.com/methodology