# K972810: OPT80 the Transportable (OPT80)

- Pathway: 510(k) (Traditional)
- Applicant: O.P.T. USA, Inc.
- Decided: Aug 26, 1997 after 29 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
Longest line of descent: 1 generation back to K930493 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930493: Quantum 3080 Surgical Table, American Sterilizer Co. (1993) Summary page 1.

## Indications for use
The OPT 80 Mobile Operating Table is designed for use during diagnostic examinations or surgical procedures to support and position a patient. It is made up of a column, movable tabletops and trolley. The tabletops allow trendelenburg, and reverse trendelenburg positioning, lateral tilting as well as back, leg and head plate movement. It has side rails for fitting additional accessories as may be required by a particular procedure. The table system is designed to hold a patient of 180 Kg. (400 Lbs.) in the positions described in the Instruction Manual and the attached Standard Equivalency Table. Officine di Protesi Trento S.p.A provides an instruction manual to inform the customer on how to properly install and start the surgical table. To avoid failure, the user must follow the manufacturer’s instructions for installation, use, cleaning and maintenance. There are secondary back-up operating devices to allow operation of the table should the primary control or power supply fail. Incorrect use and failure of the surgical table can lead to interruption of a surgical procedure and injury to the patient.

Source page: https://510kreport.com/device/K972810
Methodology: https://510kreport.com/methodology