# K891093: Aca (R) Digitoxin Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: E.I. Dupont DE Nemours & Co., Inc.
- Decided: Apr 26, 1989 after 55 days
- Product code: DCJ (Beta-Globulin, Antigen, Antiserum, Control)
- Device class: 1
- Regulation: 21 CFR 866.5160
- Recalls of this device: none
- 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; 1 cites 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
- K990255: Dimension Drug Calibrator II, Model DC49B (1999), 10 descendants of its own
- K032574: Dimension Drug Calibrator II, Model DC49C (2003), 9 descendants of its own
- K033809: Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II, Models DF113. DC49D (2004), 8 descendants of its own
- K160202: Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) (2016), 2 descendants of its own
- K061655: Dimension Vista Flex Reagent Cartridges (2006), 1 descendant of its own

Source page: https://510kreport.com/device/K891093
Methodology: https://510kreport.com/methodology