# K875280: Steris System 1 Processor and 20 Sterilant

- Pathway: 510(k) (Traditional)
- Applicant: Steris C/O Medical Device Consultants, Inc.
- Decided: Sep 13, 1988 after 264 days
- Product code: MED (Sterilant, Medical Devices)
- Device class: 2
- Regulation: 21 CFR 880.6885
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 5 cite it directly.
0 of 12 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
- K972708: Endo-Spor Plus / Hyprocide (1999), 7 descendants of its own
- K013280: Sterilox Liquid Chemical Sterilant System (2002), 6 descendants of its own
- K090036: System 1.5 Sterile Processing System (2010), 4 descendants of its own
- K101409: System IE Liquid Chemical Cterilant Processing System (2010), 3 descendants of its own
- K102462: System 1E Liquid Chemical Sterilant Processing System (2010), 2 descendants of its own

## Recalls of this device
- Aug 4, 2008 · Not classified · Z-2462-2008: During ongoing product development testing, it was discovered that, when the two inflow barbs on adapter 201048 # 4 are in a position to face one direction, the top Barblock may interfere with the top
- Mar 15, 2004 · Not classified · Z-0765-04: A defective port adapter may affect the sterilization process of the attached endoscope.
- Mar 7, 2003 · Not classified · Z-0547-03: The Steris device may not attach properly to retrofitted Olympus bronchoscopes, and become loose during the sterile processing cycle.

Source page: https://510kreport.com/device/K875280
Methodology: https://510kreport.com/methodology