# K001133: Vitro Chemistry Products ECO2 Slide & Calibrator Kit 2

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Apr 24, 2000 after 14 days
- Product code: KHS (Enzymatic, Carbon-Dioxide)
- Device class: 2
- Regulation: 21 CFR 862.1160
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K120765: Vitros Chemistry Products ECO2 Slides (2012), 2 descendants of its own
- K182072: VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides (2018), 1 descendant of its own
- K190520: VITROS XT Chemistry Products GLU-Ca Slides (2019), 0 descendants of its own
- K093611: Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit, Models CO2 DT Slides, 172 0002; (2010), 0 descendants of its own

## Recalls of this device
- Jun 12, 2013 · Class II · Z-0312-2014: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Source page: https://510kreport.com/device/K001133
Methodology: https://510kreport.com/methodology