510(k) · Cleared
ClearedOPT80 the Transportable (OPT80)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
O.P.T. USA, Inc. · FQO Table, Operating-Room, Ac-Powered
Cleared on Aug 26, 1997 as substantially equivalent to K930493 (American Sterilizer Co., 1993) after a 29-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Aug 26, 1997
- Review
- 29 days
- Class
- Class I
- Product code
- FQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930493 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK930493 Quantum 3080 Surgical TableAmerican Sterilizer Co. · 1993
- This deviceK972810 OPT80 the Transportable (OPT80)O.P.T. USA, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930493 | Quantum 3080 Surgical Table | American Sterilizer Co. | 1993 | — |
| 0 (this device) | K972810 | OPT80 the Transportable (OPT80) | O.P.T. USA, Inc. | 1997 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FQO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FQO device
- #1 K240598 Maestro System (REF100)score 10.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K930493 | Quantum 3080 Surgical TableSummary page 1…50 IMQ The general use and technological characteristics of the device do not differ significantly from those of the currently marketed AMSCO Quantum 3080 SP 510(k) No. 930493. Attached is a table which compares the operational and safety features for the OPT 80 and the Quantum 3080SP. The devices have s… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All FQO devicesFQO Table, Operating-Room, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FQO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FQO
Too few FQO 510(k)s in any year since 2007 to give a median.
Recalls per year · FQO
8in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FQO
113in 2025
MAUDE reports naming product code FQO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 61 |
| 2008 | 0 | — | 10 | 47 |
| 2009 | 1 | — | 3 | 58 |
| 2010 | 0 | — | 3 | 127 |
| 2011 | 0 | — | 7 | 101 |
| 2012 | 0 | — | 0 | 120 |
| 2013 | 0 | — | 1 | 116 |
| 2014 | 0 | — | 1 | 145 |
| 2015 | 0 | — | 2 | 108 |
| 2016 | 0 | — | 2 | 93 |
| 2017 | 0 | — | 0 | 98 |
| 2018 | 0 | — | 5 | 104 |
| 2019 | 0 | — | 0 | 118 |
| 2020 | 0 | — | 2 | 97 |
| 2021 | 0 | — | 0 | 102 |
| 2022 | 1 | — | 1 | 125 |
| 2023 | 0 | — | 2 | 187 |
| 2024 | 1 | — | 8 | 139 |
| 2025 | 0 | — | 0 | 113 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (176 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972810: OPT80 the Transportable (OPT80).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972810
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026