# K921910: Sterrad Chemical Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Medical, Inc.
- Decided: Oct 4, 1993 after 529 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.
42 later devices descend from it; 5 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K103210: Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek Heat-Seal with Sterrad Chemical Indicators (2011), 15 descendants of its own
- K013228: 3M Comply 1248 Gas Plasma Chemical Indicator (2002), 14 descendants of its own
- K150622: 3M Comply Hydrogen Peroxide Chemical Indicator 1248 (2015), 13 descendants of its own
- K170321: 3M Comply Hydrogen Peroxide Chemical Indicator 1248 (2017), 12 descendants of its own
- K183211: 3M Comply Hydrogen Peroxide Chemical Indicator (2019), 11 descendants of its own

Source page: https://510kreport.com/device/K921910
Methodology: https://510kreport.com/methodology