510(k) · Cleared
ClearedArco FP-S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A.T.S. Applicazione Tecnologie Speciali S.R.L. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Aug 13, 2021 as substantially equivalent to K182086 (A.T.S. Applicazione Tecnologie Speciali S.R.L., 2019) after a 65-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- Aug 13, 2021
- Review
- 65 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K182086 (2019). No later device cites it as a predicate yet.
- Root · 1 generation backK182086 Arco FPA.T.S. Applicazione Tecnologie Speciali S.R.L. · 2019
- This deviceK211777 Arco FP-SA.T.S. Applicazione Tecnologie Speciali S.R.L. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K182086 | Arco FP | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 2019 | — |
| 0 (this device) | K211777 | Arco FP-S | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 2021 | — |
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 18.3 · 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 |
|---|---|---|---|
| * | K182086 | Arco FPSummary page 4…Class II Product Code: OWB, OXO This is a MODIFIED device. The digital x-ray receptor panels have changed. Substantially equivalent device: K182086 Manufacturer: A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L. Trade/Device Name: ARCO FP Regulatio… | 2019 |
| † | K200022 | FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System | 2020 |
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.
- 1 other device also cites its predicate K182086.
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. 2021, 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?
ARCO FP-S is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures.
In particular, the device is to be applied during othopaedic, neuro, abdominal, vascular, thoracic and cardiac procedures.
ARCO FP-S device can be used on all patients except paediatric patients within the limit of the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211777 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211777: Arco FP-S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211777
Report an extraction error
Are you the manufacturer?
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