510(k) Report

510(k) · Cleared

Cleared

New Optional Probes for Ssa-90A

K852159510(k) TraditionalCleared Dec 2, 1985199-day reviewClass II21 CFR 892.1570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Toshiba Medical Systems · ITX Transducer, Ultrasonic, Diagnostic

Cleared on Dec 2, 1985 after a 199-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 206 later devices descend from it.

Decided
Dec 2, 1985
Review
199 days
Class
Class II
Product code
ITX
Recalls
None
Predicates
0

206 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2005: 3 descendants cleared2007: 2 descendants cleared2006: 3 descendants cleared2009: 4 descendants cleared2008: 5 descendants cleared2010: 8 descendants cleared2011: 10 descendants cleared2012: 8 descendants cleared2017: 26 descendants cleared2013: 9 descendants cleared2020: 13 descendants cleared2018: 12 descendants cleared2015: 17 descendants cleared2024: 14 descendants cleared2014: 2 descendants cleared2016: 10 descendants cleared2019: 11 descendants cleared2023: 8 descendants cleared2025: 15 descendants cleared2021: 10 descendants cleared2026: 6 descendants cleared2022: 9 descendants cleared1990200020102020
  1. This deviceK852159 New Optional Probes for Ssa-90AToshiba Medical Systems · 1985
  2. Descendant · cites it directly · 205 of its ownK990490 Ssa-320A Just Vision 200/ Ssa-325A Just VisionToshiba America Medical Systems, In.C · 1999
  3. Descendant · 2 generations on · 195 of its ownK043563 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
  4. Descendant · 3 generations on · 194 of its ownK053346 Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
  5. Descendant · 4 generations on · 193 of its ownK061189 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
  6. Descendant · 2 generations on · 192 of its ownK052113 DP-6600 Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005

Showing 5 of 206 descendants. See all descendants

Descendants cleared per year

1999: 12005: 32006: 32007: 22008: 52009: 42010: 82011: 102012: 82013: 92014: 22015: 172016: 102017: 262018: 122019: 112020: 132021: 102022: 92023: 82024: 142025: 152026: 6
1999high 26 (2017) · low 0 (2000)2026

Most influential descendants

Showing 5 of 206 · See all
  • K990490Ssa-320A Just Vision 200/ Ssa-325A Just VisionToshiba America Medical Systems, In.C · 1999 · cites it directly205descendants
  • K043563DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005 · 2 generations on195descendants
  • K053346Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model DP-9900Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005 · 3 generations on194descendants
  • K061189DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · 4 generations on193descendants
  • K052113DP-6600 Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005 · 2 generations on192descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K852159New Optional Probes for Ssa-90AToshiba Medical Systems1985—
+1K990490Ssa-320A Just Vision 200/ Ssa-325A Just VisionToshiba America Medical Systems, In.C1999—
+2K043563DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2005—
+3K053346Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2005—
+4K061189DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006—
+2K052113DP-6600 Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200530
200630
200720
200850
200940
201080
2011100
201280
201390
201420
2015170
2016100
2017260
2018120
2019110
2020130
2021100
202290
202380
2024140
2025150
202660
FIG. 1 — Lineage of K852159, 1985–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (206)

See all 206

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K990490Ssa-320A Just Vision 200/ Ssa-325A Just VisionToshiba America Medical Systems, In.C1999205

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?

  • Of its descendants, K990490 (Toshiba America Medical Systems, In.C, 1999) has gone furthest, with 205 descendants of its own.

How does its category compare?

All ITX devices

ITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ITX

4in 2025

2007: 102008: 122009: 172010: 102011: 102012: 72013: 32014: 42015: 12016: 42017: 62018: 22019: 12020: 32021: 32022: 22023: 62024: 32025: 42026 (partial year): 6
2007high 17 (2009) · low 1 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ITX

126in 2025

2007: 26 days median2008: 73 days median2009: 28 days median2010: 42 days median2011: 16 days median2012: 25 days median2013: 105 days median2014: 41 days median2016: 151 days median2017: 110 days median2020: 120 days median2021: 139 days median2023: 213 days median2024: 81 days median2025: 126 days median2026 (partial year): 158 days median
2007high 213 (2023) · low 16 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ITX

2in 2025

2008: 42009: 42010: 42011: 12012: 12014: 12015: 52017: 12018: 152020: 32021: 10, 10 Class I2022: 62023: 12024: 12025: 2
2007high 15 (2018) · low 0 (2007)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · ITX

571in 2025

2007: 162008: 392009: 232010: 302011: 342012: 292013: 382014: 432015: 1832016: 2692017: 4122018: 1302019: 1192020: 1162021: 1462022: 872023: 1382024: 9882025: 571
2007high 988 (2024) · low 16 (2007)2025

MAUDE reports naming product code ITX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071026016
20081273439
20091728423
20101042430
20111016134
2012725129
20133105038
2014441143
20151—5183
201641510269
201761101412
20182—15130
20191—0119
202031203116
2021313910 (10)146
20222—687
202362131138
20243811988
202541262571
202661580—

More from Toshiba Medical Systems

54 FDA decisions under this applicant name. See the company

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  • K954309AngiorexToshiba Medical Systems · 1995
  • K893750MRT-50A MobileToshiba Medical Systems · 1989
  • K891453Diagnostic Ultrasound Transducer: Pve-582VToshiba Medical Systems · 1989

Recent decisions in ITX

The ITX category page

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  • K254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc. · 2026
  • K260161SmartGuide Disposable Guides and GridsUC-CARE, Ltd. · 2026
  • K262474ND Needle Guidance SystemAccurate Access, LLC · 2026

https://510kreport.com/device/K852159 · printed Nov 4, 2026

Cite this page

510(k) Report. “K852159: New Optional Probes for Ssa-90A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K852159

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026