# K103219: Sterrad Sealsure Chemical Indicator Tape

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Apr 1, 2011 after 151 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: 2 generations back to K022441 (2002). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022441: Sterrad Sealsure Chemical Indicator Tape, Advanced Sterilization Products (2002) Summary page 1.
- K040742: Modification to  Sterrad Sealsure Chemical Indicator Tape, Advanced Sterilization Products (2004) Summary page 1.

## Most influential descendants
- K111519: Sterrad Sealsure Chemical Indicator Tape Model 14202 (2012), 3 descendants of its own
- K160485: VERIFY VH2O2 Indicator Tape (2016), 1 descendant of its own
- 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
- K172753: VERIFY VH2O2 Indicator Tape (2018), 0 descendants of its own

## Indications for use
STERRAD® SEALSURE® Chemical Indicator Tape is a process indicator [(Class 1 Process Indicator (ISO 11140-1)] intended for use by healthcare providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD® Sterilization Systems. MODEL — CYCLE STERRAD® 1005S — Standard STERRAD® 50 — Standard STERRAD® 200 — Standard STRASNX — Standard STERRAD® Advanced — Standard STERRAD® 100ONX — Flex EXPRESS The color of the STERRAD®D SEALSURE® Chemical Indicator Tape changes from red to gold (or lighter) when exposed to hydrogen peroxide and is intended to differentiate between processed and unprocessed loads.

Source page: https://510kreport.com/device/K103219
Methodology: https://510kreport.com/methodology