# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products, Inc.
- Decided: Jul 5, 2024 after 196 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: 11 generations back to K994055 (2002). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111518: Sterrad Chemial Indicator Strip Model 14100, Advanced Sterilization Products (2012) Summary page 8.
- K111519: Sterrad Sealsure Chemical Indicator Tape Model 14202, Advanced Sterilization Products (2012) Summary page 13.
- K192025: STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader, Advanced Sterilization Products (Asp) (2020) Summary page 18.

## Indications for use
The STERRAD™ Chemical Indicator (Cl) Strip is a process indicator per ISO 11140-1:2014 [Type 1] (to differentiate processed from unprocessed packages) and is intended for use with medical device packages to be sterilized in the following STERRAD™ Sterilization Systems: • STERRAD™ lO0S Sterilization System • STERRAD NX™ Sterilization System o STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology • STERRAD™ lO0NX Sterilization System o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear Technology o ULTRA GI™ Cycle with Integrated ALLClear Technology STERRAD™ SEALSURE™ Chemical Indicator Tape is a process indicator (ISO 1114 0-1:2014 [Type 1]) intended for use by health care providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD™ Sterilization Systems: • STERRAD™ lO0S Sterilization System • STERRAD NX™ Sterilization System o STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology • STERRAD™ lO0NX Sterilization System o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology o ULTRA GI™ Cycle with Integrated ALLClear™ Technology The color of the STERRAD SEALSURE Chemical Indicator Tape changes from red to gold (or lighter) indicated by comparator bar when exposed to hydrogen peroxide and is intended to differentiate between processed and unprocessed loads. The STERRAD VELOCITY™ Biological Indicator (B1)/Process Challenge Device (PCD), in conjunction with the STERRAD VELOCITY™ Reader, is intended to be used as a standard method for frequent monitoring and/or periodic testing of the following STERRAD™ Systems: • STERRAD™ lO0NX Sterilization System o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology o ULTRA GI™ Cycle with Integrated ALLClear Technology (for frequent monitoring only). • STERRAD NX™ Sterilization System o (STANDARD AND ADVANCED Cycles) with and without ALLClear™ Technology • STERRAD™ lO0S Sterilization System The ULTRA GI™ Process Challenge Device (PCD) Vial is used with the STERRAD VELOCITY™ Biological Indicator (Bl) for periodic testing and frequent monitoring of the ULTRA GI™ Cycle in the STERRAD™ l00NX Sterilization System with ALLClear™ Technology.

Source page: https://510kreport.com/device/K234084
Methodology: https://510kreport.com/methodology