# K920742: Hydrajust IV Urological Table

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Group, Inc.
- Decided: Apr 27, 1992 after 68 days
- Product code: IXR (Table, Radiographic, Tilting)
- Device class: 2
- Regulation: 21 CFR 892.1980
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jun 14, 2010 · Not classified · Z-1904-2010: Covidien received complaints of the Sedecal Generator failing and producing smoke at customer sites. The failure modes are located in different parts of the generator and will lead to the generator be

Source page: https://510kreport.com/device/K920742
Methodology: https://510kreport.com/methodology