# K941278: HY-Tec Automated Eia System

- Pathway: 510(k) (Traditional)
- Applicant: Hycor Biomedical, Inc.
- Decided: Mar 13, 1995 after 361 days
- Product code: DHB (System, Test, Radioallergosorbent (Rast) Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5750
- 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K081217: HY-Tec Specific and Total Ige Eia System (2008), 0 descendants of its own
- K080322: HY*Tec Extended Specific Ige Eia, MCS Assay Using Tecan Freedom Evo RSP 200 (2008), 0 descendants of its own

## Recalls of this device
- Jul 25, 2018 · Class II · Z-0224-2020: Some of the Stop Solution bottles, a caustic solution, have been reported to leak.

Source page: https://510kreport.com/device/K941278
Methodology: https://510kreport.com/methodology