510(k) · Cleared
ClearedCardiovascular Angiography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allengers Medical Systems Limited · OWB Interventional Fluoroscopic X-Ray System
Cleared on May 3, 2022 as substantially equivalent to K162859 (Philips Medical Systems Nederland B.V., 2016) after a 90-day review. Its family tree reaches back 14 generations to 1980. 2 of the 56 devices in its family, counting itself, have a Class I recall.
- Decided
- May 3, 2022
- Review
- 90 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K801623 (1980). 55 ancestors in all. No later device cites it as a predicate yet. 2 of the 56 devices in this family, counting this one, have a Class I recall.
- Root · 14 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 10 generations between
- 3 generations backK141979 Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV · 2014 · Recalled
- 2 generations backK161563 Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · Recalled
- 1 generation backK162859 Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · Recalled (Class I)
- This deviceK220311 Cardiovascular Angiography SystemAllengers Medical Systems Limited · 2022
Show all 14 generations
- Root · 14 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 13 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 12 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 11 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 10 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 9 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 8 generations backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 7 generations backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- 6 generations backK102005 Allura Xper or Table SeriesPhilips Medical Systems North America, Inc. · 2010 · Recalled
- 5 generations backK130638 Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V. · 2013 · Recalled
- 4 generations backK133292 Allura Xper FD; or TablePhilips Medical Systems Nederland B.V. · 2014 · Recalled
- 3 generations backK141979 Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV · 2014 · Recalled
- 2 generations backK161563 Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · Recalled
- 1 generation backK162859 Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · Recalled (Class I)
- This deviceK220311 Cardiovascular Angiography SystemAllengers Medical Systems Limited · 2022
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −13 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −12 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −11 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −10 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −9 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −8 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| −7 | K090745 | Artis Zee / Zeegos with SW VC14 | Siemens Medical Solutions USA, Inc. | 2009 | 7 |
| −6 | K102005 | Allura Xper or Table Series | Philips Medical Systems North America, Inc. | 2010 | 39 |
| −5 | K130638 | Alluraclarity Xper FD Series X-Ray System | Philips Medical Systems Nederland B.V. | 2013 | 39 |
| −4 | K133292 | Allura Xper FD; or Table | Philips Medical Systems Nederland B.V. | 2014 | 45 |
| −3 | K141979 | Allura Xper FD Series / Allura Xper or Table Series | Philips Medical Systems Netherland BV | 2014 | 81 |
| −2 | K161563 | Allura Xper FD series and Allura Xper OR Table series | Philips Medical Systems Nederland B.V. | 2016 | 45 |
| −1 | K162859 | Allura Xper FD series and Allura Xper OR Table series | Philips Medical Systems Nederland B.V. | 2016 | Class I |
| 0 (this device) | K220311 | Cardiovascular Angiography System | Allengers Medical Systems Limited | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 10 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 1 |
| 2004 | 3 | 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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K162859 | Allura Xper FD series and Allura Xper OR Table seriesSummary page 4…giscan FDX-VXXYY 3. Predicate Device: Device (trade) name: Allura Xper FD Series and Allura Xper OR Table series 510(K) Number : K162859 Clearance Date : December 2, 2016 Classification Name: Image-Intensified Fluoroscopic X-R… | 2016 |
| † | K203428 | Ziehm Vision RFD | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · Direct predicate · ◆ on the line of descent in FIG. 112 Class I recalls
- K033737Allura Xper FD20Philips Medical Systems North America, Inc. · 2003 · 6 generations back · ◆ in the 2003 ancestors bar of FIG. 113 Class I recalls
What does this lineage say?
- The line of descent spans 42 years and passes through 9 companies; a new generation was cleared every 1.9 years on median.
- 21 of the 55 ancestors have a recall of any class; 2 have a Class I recall.
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. 2022, 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?
The Cardiovascular Angiography System is digital system with high frequency X-Ray generator for application in cardiovascular procedures. This system used in catheterization labs uses high power x-ray pulses and digital imaging system to visualize the vascular structures of human body. Clinical applications may include (but not limited to) interventional cardiovascular procedures, Neurovascular procedures, pacemaker implantable and high end…
Read the full statement (121 words)
The Cardiovascular Angiography System is digital system with high frequency X-Ray generator for application in cardiovascular procedures. This system used in catheterization labs uses high power x-ray pulses and digital imaging system to visualize the vascular structures of human body.
Clinical applications may include (but not limited to) interventional cardiovascular procedures, Neurovascular procedures, pacemaker implantable and high end investigations.
This system should be handled by persons who have been briefed in its professional handling and who have familiarized themselves with the product by means of instructions for use. Intended use also means following the user manual and observing the conditions for inspection and maintenance.
Exclusion: This system is not recommended for Mammography.
Contraindication: Exposure of X-Ray should be avoided during pregnancy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220311 · printed Nov 4, 2026
Cite this page
510(k) Report. “K220311: Cardiovascular Angiography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K220311
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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