510(k) · Cleared
ClearedAcuson P50 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Aug 29, 2007 as substantially equivalent to K992505 (Teratech Corp., 1999) and 6 other predicates after a 14-day review. Its family tree reaches back 5 generations to 1989. 1 later device descends from it.
- Decided
- Aug 29, 2007
- Review
- 14 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 5 generations to K894632 (1989). 34 ancestors in all, the oldest K850478 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 4 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 3 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 2 generations backK991710 Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999
- 1 generation backK051334 Terason Ultrasound System with Continuous Wave SopplerTeratech Corp. · 2005
- This deviceK072266 Acuson P50 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK083114 Acuson P50 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K083114Acuson P50 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −4 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −3 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −2 | K991710 | Ssa-370A/Powervision 6000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −1 | K051334 | Terason Ultrasound System with Continuous Wave Soppler | Teratech Corp. | 2005 | — |
| 0 (this device) | K072266 | Acuson P50 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +1 | K083114 | Acuson P50 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 5 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K992505 | Teratech, Model 2000 Imaging ImagingSummary page 1…Diagnostic Ultrasonic Transducer (21 CFR 892.1570, 90-ITX) 3. PREDICATE DEVICES K992505 TERATECH Model 2000 Imaging System K010833 TERATECH Model 8C4 Endlocavity Smart Probe K012191 TERATECH Model 2000 Handhe… | 1999 |
| * | K010883 | Teratech Model 8EC4 Endocavity Smart Probe Our reading of the summary gave K010833, FDA’s number for AT Work Drug Test, Model 9177T Awt (Phamatech). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “TERATECH Model 8C4 Endocavity Smart Probe”. | 2001 |
| * | K012191 | Teratech Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging ModesSummary page 1…(21 CFR 892.1570, 90-ITX) 3. PREDICATE DEVICES K992505 TERATECH Model 2000 Imaging System K010833 TERATECH Model 8C4 Endlocavity Smart Probe K012191 TERATECH Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes K030191 SIEMENS TM… | 2001 |
| * | K030191 | Terason Model 2000/Bas Portable Ultrasound SystemSummary page 1…K010833 TERATECH Model 8C4 Endlocavity Smart Probe K012191 TERATECH Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes K030191 SIEMENS TM Model 2000/BAS Portable Ultrasound Systems K040840 TERATECH Model 10V5 Smart Probe K043278 TERATECH Model… | 2003 |
| * | K040840 | Teratech Model 10V5 Smart ProbeSummary page 1…ATECH Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes K030191 SIEMENS TM Model 2000/BAS Portable Ultrasound Systems K040840 TERATECH Model 10V5 Smart Probe K043278 TERATECH Model 810C4, 810L4, and 1OLAP4 Probes K051334 TERASON~m Ultrasound Sy… | 2004 |
| * | K043278 | Teratech Model 8IOC4, 8IOL4 & 10LAP4 ProbesSummary page 1…with Doppler and Harmonic Imaging Modes K030191 SIEMENS TM Model 2000/BAS Portable Ultrasound Systems K040840 TERATECH Model 10V5 Smart Probe K043278 TERATECH Model 810C4, 810L4, and 1OLAP4 Probes K051334 TERASON~m Ultrasound System with Continuous Wave (CW)… | 2004 |
| * | K051334 | Terason Ultrasound System with Continuous Wave SopplerSummary page 1…191 SIEMENS TM Model 2000/BAS Portable Ultrasound Systems K040840 TERATECH Model 10V5 Smart Probe K043278 TERATECH Model 810C4, 810L4, and 1OLAP4 Probes K051334 TERASON~m Ultrasound System with Continuous Wave (CW) Doppler and add-to-file submissions… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083114 | Acuson P50 Ultrasound System | 2009 | 0 |
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 18 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 34 ancestors have a recall of any class.
- Of its descendants, K083114 (Siemens Medical Solutions USA, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K992505.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
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:
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/K072266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072266: Acuson P50 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/K072266
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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