510(k) Report

510(k) · Cleared

Cleared

Amsco Surgical Table

K971307510(k) TraditionalCleared Jun 27, 199780-day reviewClass I21 CFR 878.4960

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

STERIS Corporation · FQO Table, Operating-Room, Ac-Powered

Cleared on Jun 27, 1997 after an 80-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 12 later devices descend from it.

Decided
Jun 27, 1997
Review
80 days
Class
Class I
Product code
FQO
Recalls
None
Predicates
0

12 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2013: 1 descendant cleared2011: 1 descendant cleared2014: 1 descendant cleared2017: 1 descendant cleared2019: 1 descendant cleared2021: 1 descendant cleared2025: 2 descendants cleared2023: 2 descendants cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK971307 Amsco Surgical TableSTERIS Corporation · 1997
  2. Descendant · cites it directly · 11 of its ownK090136 Steris Cmax XLT Surgical TableSTERIS Corporation · 2009 · Recalled
  3. Descendant · 2 generations on · 10 of its ownK112109 The Kinegraph Vma Software, the Motion Normalizer Patient Handling…Ortho Kinematics, Inc. · 2011
  4. Descendant · 2 generations on · 9 of its ownK130743 The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0…Ortho Kinematics, Inc. · 2013
  5. Descendant · 3 generations on · 8 of its ownK133875 The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2…Ortho Kinematics, Inc. · 2014 · Recalled
  6. Descendant · 4 generations on · 7 of its ownK172327 VMA™ System version 3.0Ortho Kinematics, Inc. · 2017

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2009: 12011: 12013: 12014: 12017: 12019: 12021: 12023: 22025: 22026: 1
2009high 2 (2023) · low 0 (2010)2026

Most influential descendants

Showing 5 of 12 · See all
  • K090136Steris Cmax XLT Surgical TableSTERIS Corporation · 2009 · cites it directly11descendants
  • K112109The Kinegraph Vma Software, the Motion Normalizer Patient Handling and Data Collection…Ortho Kinematics, Inc. · 2011 · 2 generations on10descendants
  • K130743The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0; the Motion…Ortho Kinematics, Inc. · 2013 · 2 generations on9descendants
  • K133875The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2, the Motion…Ortho Kinematics, Inc. · 2014 · 3 generations on8descendants
  • K172327VMA™ System version 3.0Ortho Kinematics, Inc. · 2017 · 4 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K971307Amsco Surgical TableSTERIS Corporation1997—
+1K090136Steris Cmax XLT Surgical TableSTERIS Corporation20094
+2K112109The Kinegraph Vma Software, the Motion Normalizer Patient Handling and Data…Ortho Kinematics, Inc.2011—
+2K130743The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0; the Motion…Ortho Kinematics, Inc.2013—
+3K133875The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2, the Motion…Ortho Kinematics, Inc.20144
+4K172327VMA™ System version 3.0Ortho Kinematics, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201110
201310
201410
201710
201910
202110
202320
202520
202610
FIG. 1 — Lineage of K971307, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K240598 Maestro System (REF100)score 10.7 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (12)

See all 12

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K090136Steris Cmax XLT Surgical TableSTERIS Corporation200911

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?

  • Of its descendants, K090136 (STERIS Corporation, 2009) has gone furthest, with 11 descendants of its own.

How does its category compare?

All FQO devices

FQO Table, Operating-Room, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FQO

1in 2024

2009: 12022: 12024: 1
2007high 1 (2009) · low 0 (2007)2026

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

2008: 102009: 32010: 32011: 72013: 12014: 12015: 22016: 22018: 52020: 22022: 12023: 22024: 82026 (partial year): 1
2007high 10 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FQO

113in 2025

2007: 612008: 472009: 582010: 1272011: 1012012: 1202013: 1162014: 1452015: 1082016: 932017: 982018: 1042019: 1182020: 972021: 1022022: 1252023: 1872024: 1392025: 113
2007high 187 (2023) · low 47 (2008)2025

MAUDE reports naming product code FQO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—061
20080—1047
20091—358
20100—3127
20110—7101
20120—0120
20130—1116
20140—1145
20150—2108
20160—293
20170—098
20180—5104
20190—0118
20200—297
20210—0102
20221—1125
20230—2187
20241—8139
20250—0113
20260—1—

What is it indicated for?

The AMSCO® Surgical Table is a mobile, electro-hydraulically operated general surgical table that provides flexible articulation and image amplification of the surgical patient.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K971307: Amsco Surgical Table.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971307

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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