# K971988: Allen, Ultra and Smart Sockets

- Pathway: 510(k) (Traditional)
- Applicant: Allen Medical Systems, Inc.
- Decided: Jul 11, 1997 after 43 days
- Product code: FQO (Table, Operating-Room, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 878.4960
- Recalls of this device: none
- 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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Devices are intended to attach boot stirrups to-opefating rcom table rail or cysto table rail during surgical or diagnostic procedures requiring positioning and support of the patient’s legs.

Source page: https://510kreport.com/device/K971988
Methodology: https://510kreport.com/methodology
