# K192025: STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products (Asp)
- Decided: Jan 23, 2020 after 178 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: 10 generations back to K994055 (2002). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182404: STERRAD VELOCITY Biological Indicator, Advanced Sterilization Products (Asp) (2018) Summary page 4.

## Most influential descendants
- K234084: STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count) (2024), 0 descendants of its own

## Indications for use
STERRAD VELOCITY® Biological Indicator/Process Challenge Device, in conjunction with the STERRAD VELOCITY Reader, is intended to be used as a standard method for frequent monitoring and periodic testing of the following STERRAD Sterilization Systems: • STERRAD® I00NX (STANDARD, FLEX, EXPRESS, and DUO Cycles) with and without ALLClear® Technology • STERRAD NX® (STANDARD and ADVANCED Cycles) with and without ALLClear® Technology • STERRAD® 1 00S

Source page: https://510kreport.com/device/K192025
Methodology: https://510kreport.com/methodology