510(k) · Cleared
Recalled · Class II · 2025Clearvue 350/550 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Health Care · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Feb 17, 2012 as substantially equivalent to K043535 (Philips Ultrasound, Inc., 2005) after a 15-day review. Its family tree reaches back 1 generation to 2005. 2 of the 93 devices in its family, counting itself, have a Class I recall. 91 later devices descend from it. It has been recalled 8 times.
- Decided
- Feb 17, 2012
- Review
- 15 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 1 generation to K043535 (2005). 91 later devices descend from it, 3 citing it directly. 2 of the 93 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK043535 HD11 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2005 · Recalled
- This deviceK120321 Clearvue 350/550 Diagnostic Ultrasound SystemPhilips Health Care · 2012
- Descendant · cites it directly · 87 of its ownK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 79 of its ownK152899 Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 43 of its ownK162549 Lumify Ultrasound SystemPhilips Health Care · 2016 · Recalled
- Descendant · 4 generations on · 31 of its ownK192226 Lumify Diagnostic Ultrasound SystemPhilips Health Care · 2019 · Recalled
- Descendant · 3 generations on · 28 of its ownK163138 Clarius Ultrasound SystemClarius Mobile Health Corp. · 2016
Showing 5 of 91 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 91 · See all- K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · cites it directly87descendants
- K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · 2 generations on79descendants
- K162549Lumify Ultrasound SystemPhilips Health Care · 2016 · 3 generations on43descendants
- K192226Lumify Diagnostic Ultrasound SystemPhilips Health Care · 2019 · 4 generations on31descendants
- K163138Clarius Ultrasound SystemClarius Mobile Health Corp. · 2016 · 3 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K043535 | HD11 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2005 | 36 |
| 0 (this device) | K120321 | Clearvue 350/550 Diagnostic Ultrasound System | Philips Health Care | 2012 | — |
| +1 | K133833 | Nuvis Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2014 | 3 |
| +2 | K152899 | Philips Lumify Diagnostic Ultrasound System | Philips Healthcare, Inc. | 2015 | 4 |
| +3 | K162549 | Lumify Ultrasound System | Philips Health Care | 2016 | 6 |
| +4 | K192226 | Lumify Diagnostic Ultrasound System | Philips Health Care | 2019 | 5 |
| +3 | K163138 | Clarius Ultrasound System | Clarius Mobile Health Corp. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 12 | 0 |
| 2022 | 7 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 14 | 2 |
| 2026 | 13 | 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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 |
|---|---|---|---|
| * | K043535 | HD11 Diagnostic Ultrasound SystemSummary page 1…892.1570 Transducer, Ultrasonic, diagnostic 90 ITX 3) Substantially Equivalent Device HD I I Diagnostic Ultrasound System K043535 Page I 3) Device Description ClearVue 3 50/550 is a new general… | 2005 |
What descends from it? (91)
See all 913 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 5, 2025 | Class III | Z-1625-2026 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2373-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2364-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2391-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2353-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| May 28, 2025 | Class II | Z-2050-2025 | Process control | Ultrasound transducer devices were refurbished beyond their useful life. |
| May 28, 2025 | Class II | Z-2055-2025 | 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… |
The 5 latest of 8 recalls; the web page lists all.
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.
What does this lineage say?
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
The ClearVue 350/550 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in the following modes: B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Harmonics, iSCAN, X-Res, angio, 3D (freehand), and SonoCT. The system may also be used in biopsy guidance and to assist in infertility monitoring of follicle development (OB). The system is indicated for diagnostic…
Read the full statement (240 words)
The ClearVue 350/550 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in the following modes: B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Harmonics, iSCAN, X-Res, angio, 3D (freehand), and SonoCT. The system may also be used in biopsy guidance and to assist in infertility monitoring of follicle development (OB). The system is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications, as listed in FDA's Diagnostic Ultrasound Indications for Use Forms (included in the submittal):
Fetal / Obstetric
Abdominal
Pediatric
Small Organ (thyroid, scrotum, prostate, breast)
Neonatal Cephalic
Adult Cephallic
Trans-rectal
Trans-vaginal
Musculoskeletal (conventional)
Musculoskeletal (superficial)
Other - Gynecological
Cardiac Adult
Cardiac Pediatric
Cardiac Other - Fetal
Peripheral Vessel
Peripheral Vessel Other - Carotid
The clinical environments where the ClearVue 350/550 Diagnostic Ultrasound System can be used include hospital, clinical and medical office settings for diagnosis of patients. The use models for ClearVue 350/550 are within the scope of and substantially equivalent to current indications for use for Diagnostic Ultrasound System.
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:
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/K120321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120321: Clearvue 350/550 Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120321
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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