510(k) · Cleared
ClearedXPLUS 35 Series (XPLUS 35, XPLUS 35FD)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gemss Healthcare CO., LTD. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Nov 16, 2023 as substantially equivalent to K091918 (Genoray Co., Ltd., 2009) after a 49-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Nov 16, 2023
- Review
- 49 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010435 (2001). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK010435 Philips BV Pulsera/EnduraPhilips Medical Systems, Inc. · 2001 · Recalled
- 1 generation backK091918 Zen-2090 Pro, Fluoroscopic X-Ray System, Model Zen-2090 ProGenoray Co., Ltd. · 2009
- This deviceK233200 XPLUS 35 Series (XPLUS 35, XPLUS 35FD)Gemss Healthcare CO., LTD. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010435 | Philips BV Pulsera/Endura | Philips Medical Systems, Inc. | 2001 | 12 |
| −1 | K091918 | Zen-2090 Pro, Fluoroscopic X-Ray System, Model Zen-2090 Pro | Genoray Co., Ltd. | 2009 | — |
| 0 (this device) | K233200 | XPLUS 35 Series (XPLUS 35, XPLUS 35FD) | Gemss Healthcare CO., LTD. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.2 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K091918 | Zen-2090 Pro, Fluoroscopic X-Ray System, Model Zen-2090 ProSummary page 4…nsified Fluoroscopic X-ray System - Device Class: Class II - Product Code: OWB - Subsequence product code: JAA, OXO 3. Predicate Device - K Number: K091918 - Manufacturer: GENORAY Co., Ltd. - Trade Name: ZEN-2090 Pro - Regulation Number: 21CFR 892.1650 - Regulation… | 2009 |
| † | K222080 | Garion Image-Intensified Fluoroscopic X-Ray System, Mobile | 2022 |
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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 14.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 2 other devices also cite its predicate K091918.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
XPlus 35 Series (XPLUS 35, XPLUS 35FD) are mobile digital C-arms designed to provide fluoroscopic and radiographic images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include endoscopy, orthopedic, neurologic, critical care and emergency room procedures.
i.e. surgical interventions needing X-ray imaging and/or guidance and interventions inside and outside the operating room.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233200 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233200: XPLUS 35 Series (XPLUS 35, XPLUS 35FD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233200
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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