# DEN110002: System 1E Process Biological Monitoring Kit

- Pathway: De Novo (Post-NSE)
- Applicant: STERIS Corporation
- Decided: Mar 30, 2012 after 242 days
- Product code: OVY (Liquid Chemical Processing System)
- Device class: 2
- Regulation: 21 CFR 880.6887
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K122509: Vertiflex Spinous Process Fixation Plate (2012), 18 descendants of its own
- K132968: Univise Spinous Process Fixation Plate (35MM, 40MM) (2013), 12 descendants of its own
- K140046: Spinous Process Fusion (SPF) Plate (2015), 9 descendants of its own
- K151741: HA Minuteman G3 MIS Fusion Plate (2015), 8 descendants of its own
- K163428: HA Minuteman G3-R MIS Fusion Plate (2017), 7 descendants of its own

Source page: https://510kreport.com/device/DEN110002
Methodology: https://510kreport.com/methodology