510(k) · Cleared
ClearedAllen, Ultra and Smart Sockets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allen Medical Systems, Inc. · FQO Table, Operating-Room, Ac-Powered
Cleared on Jul 11, 1997 after a 43-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 11, 1997
- Review
- 43 days
- Class
- Class I
- Product code
- FQO
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971988: Allen, Ultra and Smart Sockets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971988
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026