510(k) · Cleared
Recalled · Class II · 2025Philips IU22 Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Ultrasound, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Oct 4, 2004 as substantially equivalent to K040227 (Philips Ultrasound, 2004) and 2 other predicates after a 14-day review. Its family tree reaches back 3 generations to 1995. 6 of the 890 devices in its family, counting itself, have a Class I recall. 882 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 4, 2004
- Review
- 14 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 3 generations to K934139 (1995). 7 ancestors in all. 882 later devices descend from it, 12 citing it directly. 6 of the 890 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 2 generations backK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
- 1 generation backK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
- This deviceK042540 Philips IU22 Ultrasound SystemPhilips Ultrasound, Inc. · 2004
- Descendant · cites it directly · 588 of its ownK093563 IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 527 of its ownK102041 AixplorerSupersonic Imagine · 2010
- Descendant · 3 generations on · 525 of its ownK112255 AixplorerSupersonic Imagine · 2012
- Descendant · 2 generations on · 405 of its ownK121329 AixplorerSupersonic Imagine · 2012
- Descendant · 3 generations on · 312 of its ownK132274 AixplorerSupersonic Imagine · 2013
Showing 5 of 882 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 882 · See all- K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · cites it directly588descendants
- K102041AixplorerSupersonic Imagine · 2010 · 2 generations on527descendants
- K112255AixplorerSupersonic Imagine · 2012 · 3 generations on525descendants
- K121329AixplorerSupersonic Imagine · 2012 · 2 generations on405descendants
- K132274AixplorerSupersonic Imagine · 2013 · 3 generations on312descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| −2 | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
| −1 | K022824 | Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X… | Tomtec Imaging Systems GmbH | 2002 | — |
| 0 (this device) | K042540 | Philips IU22 Ultrasound System | Philips Ultrasound, Inc. | 2004 | — |
| +1 | K093563 | IU22 Ultrasound System and Transducers | Philips Ultrasound, Inc. | 2010 | 2 |
| +2 | K102041 | Aixplorer | Supersonic Imagine | 2010 | — |
| +3 | K112255 | Aixplorer | Supersonic Imagine | 2012 | — |
| +2 | K121329 | Aixplorer | Supersonic Imagine | 2012 | — |
| +3 | K132274 | Aixplorer | Supersonic Imagine | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 13 | 0 |
| 2009 | 9 | 0 |
| 2010 | 17 | 0 |
| 2011 | 21 | 0 |
| 2012 | 23 | 0 |
| 2013 | 36 | 0 |
| 2014 | 38 | 0 |
| 2015 | 49 | 0 |
| 2016 | 57 | 1 |
| 2017 | 73 | 2 |
| 2018 | 64 | 0 |
| 2019 | 48 | 0 |
| 2020 | 73 | 1 |
| 2021 | 56 | 0 |
| 2022 | 58 | 0 |
| 2023 | 51 | 0 |
| 2024 | 57 | 0 |
| 2025 | 74 | 2 |
| 2026 | 54 | 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.
6 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 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? (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 |
|---|---|---|---|
| * | K040227 | Qlab Quantification SoftwareSummary page 1…lly Equivalent Devices Philips Ultrasound believes that the iU22 system and transducers are substantially equivalent to the following currently marketed devices: QLAB (K040227;) LVAnalysis (K022824;) and M2424 (K022303) 4) Device Description & Technical Comparison to Predicate Devices Th… | 2004 |
| * | K022824 | Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X & Surgical…Summary page 1…Philips Ultrasound believes that the iU22 system and transducers are substantially equivalent to the following currently marketed devices: QLAB (K040227;) LVAnalysis (K022824;) and M2424 (K022303) 4) Device Description & Technical Comparison to Predicate Devices The iU22 system and tran… | 2002 |
| * | K022303 | Philips M2424 Diagnostic Ultrasound System &Philips 21315 Diagnostic Ultrasound TransducerSummary page 1…believes that the iU22 system and transducers are substantially equivalent to the following currently marketed devices: QLAB (K040227;) LVAnalysis (K022824;) and M2424 (K022303) 4) Device Description & Technical Comparison to Predicate Devices The iU22 system and transducer(s) function in… | 2002 |
What descends from it? (882)
See all 88212 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093563 | IU22 Ultrasound System and Transducers | 2010 | 588 |
| K132304 | Epiq Diagnostic Ultrasound System | 2013 | 211 |
| K060949 | DP-6600 Digital Ultrasonic Diagnostic Imaging System | 2006 | 191 |
| K063500 | DC-6 Diagnostic Ultrasound System | 2006 | 189 |
| K072164 | DC-6 Diagnostic Ultrasound System | 2007 | 188 |
| K083001 | M5 Diagnostic Ultrasound System | 2008 | 179 |
| K052202 | Axiom Artis - Modular Angiographic System | 2006 | 154 |
| K082326 | Zonare Ultra Ultrasound System | 2008 | 133 |
| K130159 | Qlab Quantification Software Heart Model | 2013 | 92 |
| K120525 | Qlab Quantification Software | 2012 | 92 |
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 5, 2025 | Class III | Z-1627-2026 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2407-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| May 28, 2025 | Class II | Z-2058-2025 | Process control | Ultrasound transducer devices were refurbished beyond their useful life. |
| Jun 30, 2023 | Class II | Z-2517-2023 | Process control | Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric shock if the built-in… |
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.
- K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · 7 generations on · ◆ in the 2016 descendants bar of FIG. 112 Class I recalls
- K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 7 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
- K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 8 generations on · ◆ in the 2017 descendants bar of FIG. 19 Class I recalls
- K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 9 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K093563 (Philips Ultrasound, Inc., 2010) has gone furthest, with 588 descendants of its own.
- 4 other devices also cite its predicate K040227.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042540 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042540: Philips IU22 Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042540
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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