# K022441: Sterrad Sealsure Chemical Indicator Tape

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Oct 8, 2002 after 75 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
No predicates in its family tree.
6 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) STERRAD® Chemical Indicator Tape: named in the summary without a submission number

## Most influential descendants
- K040742: Modification to  Sterrad Sealsure Chemical Indicator Tape (2004), 5 descendants of its own
- K103219: Sterrad Sealsure Chemical Indicator Tape (2011), 4 descendants of its own
- 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

## Indications for use
STERRAD® SealSure™ Chemical Indicator Tape is a process indicator intended for use by health care providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD® Sterilization System. The color of the STERRAD® 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. Reference the color comparator bars on the package box label.

Source page: https://510kreport.com/device/K022441
Methodology: https://510kreport.com/methodology