510(k) · Cleared
Recalled · Class II · 2014Steris Cmax XLT Surgical Table
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · FQO Table, Operating-Room, Ac-Powered
Cleared on Mar 20, 2009 as substantially equivalent to K041924 (STERIS Corporation, 2004) and 2 other predicates after a 58-day review. Its family tree reaches back 2 generations to 1995. 11 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 20, 2009
- Review
- 58 days
- Class
- Class I
- Product code
- FQO
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 2 generations to K942948 (1995). 4 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK942948 Stryker Powered StretcherStryker Corp. · 1995
- 1 generation backK022309 Stryker Powered Wheeled StretcherStryker Corp. · 2002 · Recalled
- This deviceK090136 Steris Cmax XLT Surgical TableSTERIS Corporation · 2009
- Descendant · cites it directly · 10 of its ownK112109 The Kinegraph Vma Software, the Motion Normalizer Patient Handling…Ortho Kinematics, Inc. · 2011
- Descendant · cites it directly · 9 of its ownK130743 The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0…Ortho Kinematics, Inc. · 2013
- Descendant · 2 generations on · 8 of its ownK133875 The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2…Ortho Kinematics, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 7 of its ownK172327 VMA™ System version 3.0Ortho Kinematics, Inc. · 2017
- Descendant · 4 generations on · 6 of its ownK192109 KOALAIb Lab GmbH · 2019
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K112109The Kinegraph Vma Software, the Motion Normalizer Patient Handling and Data Collection…Ortho Kinematics, Inc. · 2011 · cites it directly10descendants
- K130743The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0; the Motion…Ortho Kinematics, Inc. · 2013 · cites it directly9descendants
- K133875The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2, the Motion…Ortho Kinematics, Inc. · 2014 · 2 generations on8descendants
- K172327VMA™ System version 3.0Ortho Kinematics, Inc. · 2017 · 3 generations on7descendants
- K192109KOALAIb Lab GmbH · 2019 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942948 | Stryker Powered Stretcher | Stryker Corp. | 1995 | — |
| −1 | K022309 | Stryker Powered Wheeled Stretcher | Stryker Corp. | 2002 | 6 |
| 0 (this device) | K090136 | Steris Cmax XLT Surgical Table | STERIS Corporation | 2009 | — |
| +1 | K112109 | The Kinegraph Vma Software, the Motion Normalizer Patient Handling and Data… | Ortho Kinematics, Inc. | 2011 | — |
| +1 | K130743 | The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0; the Motion… | Ortho Kinematics, Inc. | 2013 | — |
| +2 | K133875 | The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2, the Motion… | Ortho Kinematics, Inc. | 2014 | 4 |
| +3 | K172327 | VMA™ System version 3.0 | Ortho Kinematics, Inc. | 2017 | — |
| +4 | K192109 | KOALA | Ib Lab GmbH | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
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? (3)
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 |
|---|---|---|---|
| * | K041924 | Hausted Powertran Series StretcherSummary page 2…me: Operating Table classified as Class I device (Product Code [FQO] per 21 CFR 878.4960 2. Predicate Devices * K041924 Hausted POWERTRAN Series Stretcher * K971307 Amsco 3085SP Surgical Table * K022309 Stryker ZOOM motorized Stretcher… | 2004 |
| * | K971307 | Amsco Surgical TableSummary page 2…device (Product Code [FQO] per 21 CFR 878.4960 2. Predicate Devices * K041924 Hausted POWERTRAN Series Stretcher * K971307 Amsco 3085SP Surgical Table * K022309 Stryker ZOOM motorized Stretcher 3. Description of Device The STERIS ® 508… | 1997 |
| * | K022309 | Stryker Powered Wheeled StretcherSummary page 2…roduct Code [FQO] per 21 CFR 878.4960 2. Predicate Devices * K041924 Hausted POWERTRAN Series Stretcher * K971307 Amsco 3085SP Surgical Table * K022309 Stryker ZOOM motorized Stretcher 3. Description of Device The STERIS ® 5085 SRT Surgical Table is a mobile, electro-hyd… | 2002 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2014 | Class II | Z-0196-2015 | Device Design | The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignment during extreme table articulation, excessive side force on the table column, or pressure on the base of the table. Severe damage to the… |
| Apr 6, 2012 | Class II | Z-2426-2012 | Device Design | STERIS has learned from Customer feedback and field service experience that damage from external impact to the table hydraulic column can cause the stainless steel shroud sections covering the table hydraulic column to become misaligned… |
| Oct 17, 2011 | Not classified | Z-0279-2012 | Nonconforming Material/Component | Some hydraulic column cylinders installed in certain 5085 and 5085SRT Surgical Tables were assembled by their supplier with incorrect snap rings and an anomaly was present in the tilt cylinder. This error may affect the user's ability to… |
| May 14, 2010 | Not classified | Z-1941-2010 | Nonconforming Material/Component | STERIS has learned that a limited quantity of manifold assemblies were manufactured by our supplier with incorrect washers and springs in the valves of the manifold. This supplier error has the potential to cause: a) an inability to… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 7.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K112109 (Ortho Kinematics, Inc., 2011) has gone furthest, with 10 descendants of its own.
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. 2009, this device’s year, is highlighted.
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 STERIS ® 5085 SRT is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. The STERIS 5085 SRT accommodates all general surgical procedures including but not limited to, cardiac and vascular, endoscopic, gynecology, urology, nephrectomy, neurology, ophthalmologic, orthopedics and other procedures requiring intraoperative fluoroscopic C-arm imaging and also supports laparoscopic…
Read the full statement (99 words)
The STERIS ® 5085 SRT is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. The STERIS 5085 SRT accommodates all general surgical procedures including but not limited to, cardiac and vascular, endoscopic, gynecology, urology, nephrectomy, neurology, ophthalmologic, orthopedics and other procedures requiring intraoperative fluoroscopic C-arm imaging and also supports laparoscopic surgical technique for the largest surgical patients.
The STERIS® 5085 SRT enables patient transport on hard level surfaces within the surgical suite (from pre-operative areas to the operating room and again from the operating room to post operative recovery).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090136 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090136: Steris Cmax XLT 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/K090136
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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