510(k) Report

510(k) · Cleared

Cleared

Terason Echo T/3000 Ultrasound System with Stress Echo

K080234510(k) TraditionalCleared Feb 14, 200815-day reviewClass II21 CFR 892.1560

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

Teratech Corp. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Feb 14, 2008 as substantially equivalent to K021497 (Acuson Corp., 2002) and 1 other predicate after a 15-day review. Its family tree reaches back 4 generations to 1994. 84 later devices descend from it.

Decided
Feb 14, 2008
Review
15 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K934041 (1994). 20 ancestors in all, the oldest K891689 (1989). 84 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2001: 1 other ancestor2000: 2 other ancestors1999: 4 other ancestors1997: 2 other ancestors1995: 2 other ancestors1994: 2 other ancestors1992: 1 other ancestor1989: 1 other ancestor2011: 2 descendants cleared2012: 1 descendant cleared2013: 3 descendants cleared2018: 3 descendants cleared2014: 4 descendants cleared2015: 4 descendants cleared2020: 10 descendants cleared2016: 7 descendants cleared2017: 5 descendants cleared2019: 4 descendants cleared2022: 11 descendants cleared2021: 8 descendants cleared2023: 5 descendants cleared2026: 6 descendants cleared2025: 7 descendants cleared2024: 4 descendants clearedK934041 · Hewlett Packard Conos Ultrasound Imaging System Modification · Hewlett-Packard Co. · 1994K964309 · Sonos 2000, Sonos 2500 (M2406 a) · Hewlett-Packard Co. · 1997K982800 · Ecton Lynx Ultrasound System · Ecton, Inc. · 1998K021497 · Cypress Ultrasound System · Acuson Corp. · 2002 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 9 other ancestors3 generations back: 6 other ancestors 1 generation forward: 3 descendants2 generations forward: 8 descendants3 generations forward: 8 descendants4 generations forward: 15 descendants5 generations forward: 11 descendants6 generations forward: 10 descendants7 generations forward: 14 descendants8 generations forward: 9 descendants9 generations forward: 4 descendants10 generations forward: 2 descendants K021497 · Cypress Ultrasound System · Acuson Corp. · 2002 · recalledK982800 · Ecton Lynx Ultrasound System · Ecton, Inc. · 1998K964309 · Sonos 2000, Sonos 2500 (M2406 a) · Hewlett-Packard Co. · 1997K934041 · Hewlett Packard Conos Ultrasound Imaging System Modification · Hewlett-Packard Co. · 19940+5+10
  1. Root · 4 generations backK934041 Hewlett Packard Conos Ultrasound Imaging System ModificationHewlett-Packard Co. · 1994
  2. 3 generations backK964309 Sonos 2000, Sonos 2500 (M2406 a)Hewlett-Packard Co. · 1997
  3. 2 generations backK982800 Ecton Lynx Ultrasound SystemEcton, Inc. · 1998
  4. 1 generation backK021497 Cypress Ultrasound SystemAcuson Corp. · 2002 · Recalled
  5. This deviceK080234 Terason Echo T/3000 Ultrasound System with Stress EchoTeratech Corp. · 2008
  6. Descendant · cites it directly · 74 of its ownK112953 Terason T3000 Ultrasound Systems with Updated Needle Guidance GraphicsTeratech Corp. · 2012
  7. Descendant · 2 generations on · 52 of its ownK130173 Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013 · Recalled
  8. Descendant · 3 generations on · 50 of its ownK133454 Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013
  9. Descendant · 4 generations on · 46 of its ownK142017 X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2014
  10. Descendant · 4 generations on · 45 of its ownK152209 FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2015

Showing 5 of 84 descendants. See all descendants

Descendants cleared per year

2011: 22012: 12013: 32014: 42015: 42016: 72017: 52018: 32019: 42020: 102021: 82022: 112023: 52024: 42025: 72026: 6
2011high 11 (2022) · low 1 (2012)2026

Most influential descendants

Showing 5 of 84 · See all
  • K112953Terason T3000 Ultrasound Systems with Updated Needle Guidance GraphicsTeratech Corp. · 2012 · cites it directly74descendants
  • K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013 · 2 generations on52descendants
  • K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013 · 3 generations on50descendants
  • K142017X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2014 · 4 generations on46descendants
  • K152209FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2015 · 4 generations on45descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K934041Hewlett Packard Conos Ultrasound Imaging System ModificationHewlett-Packard Co.1994—
−3K964309Sonos 2000, Sonos 2500 (M2406 a)Hewlett-Packard Co.1997—
−2K982800Ecton Lynx Ultrasound SystemEcton, Inc.1998—
−1K021497Cypress Ultrasound SystemAcuson Corp.20022
0 (this device)K080234Terason Echo T/3000 Ultrasound System with Stress EchoTeratech Corp.2008—
+1K112953Terason T3000 Ultrasound Systems with Updated Needle Guidance GraphicsTeratech Corp.2012—
+2K130173Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc.20131
+3K133454Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc.2013—
+4K142017X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.2014—
+4K152209FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199210
199420
199520
199720
199940
200020
200110
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201210
201330
201440
201540
201670
201750
201830
201940
2020100
202180
2022110
202350
202440
202570
202660
FIG. 1 — Lineage of K080234, 1994–2026Source: 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), 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 IYO? 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. #1 K243937 Accuro 3Sscore 20.5 · 18 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? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K021497Cypress Ultrasound System
Summary page 1
…Diagnostic Ultrasonic Transducer (21 CFR 892.1570, 90-ITX) 3. PREDICATE DEVICES Acuson Cypress Ultrasound System K021497 (Stress Echo) Acuson Sequoia Diagnostic Ultrasound System Signature II K022567 (TEE-V5M) ALOKA SSD-3500 Ultra…
Acuson Corp.20022
*K022567Sequoia Signature II Diagnostic Ultrasound System
Summary page 1
…570, 90-ITX) 3. PREDICATE DEVICES Acuson Cypress Ultrasound System K021497 (Stress Echo) Acuson Sequoia Diagnostic Ultrasound System Signature II K022567 (TEE-V5M) ALOKA SSD-3500 Ultrasound System (UST-536, equiv. To UST-534) K021497 TERATECH Corp. 510(k)…
Acuson Corp.2002—

Also cleared against K021497: 4 other devices →

What descends from it? (84)

See all 84

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K112953Terason T3000 Ultrasound Systems with Updated Needle Guidance GraphicsTeratech Corp.201274
K110020Terason T3200 Ultrasound SystemTeratech Corp.201113
K110482Prosound C3 / C3 CV Ultrasound SystemsTeratech Corp.20114

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 14 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
  • 3 of the 20 ancestors have a recall of any class.
  • Of its descendants, K112953 (Teratech Corp., 2012) has gone furthest, with 74 descendants of its own.
  • 4 other devices also cite its predicate K021497.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · IYO

7in 2025

2007: 202008: 142009: 132010: 152011: 112012: 152013: 172014: 142015: 192016: 102017: 192018: 142019: 132020: 112021: 152022: 52023: 112024: 102025: 72026 (partial year): 10
2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007: 17 days median2008: 36 days median2009: 79 days median2010: 113 days median2011: 69 days median2012: 68 days median2013: 50 days median2014: 63 days median2015: 46 days median2016: 36 days median2017: 72 days median2018: 56 days median2019: 59 days median2020: 57 days median2021: 64 days median2022: 190 days median2023: 177 days median2024: 220 days median2025: 171 days median2026 (partial year): 139 days median
2007high 220 (2024) · low 17 (2007)2026

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

Recalls per year · IYO

1in 2022

2007: 42008: 52009: 92010: 82012: 22013: 32014: 22015: 12018: 12019: 12021: 112022: 12026 (partial year): 1
2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007: 392008: 202009: 272010: 202011: 582012: 782013: 4362014: 3042015: 2682016: 2542017: 2382018: 3682019: 5372020: 4982021: 6172022: 5112023: 5272024: 6402025: 485
2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, 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
20072017439
20081436520
20091379927
201015113820
20111169058
20121568278
201317503436
201414632304
201519461268
201610360254
201719720238
201814561368
201913591537
202011570498
2021156411617
202251901511
2023111770527
2024102200640
202571710485
2026101391—

What is it indicated for?

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Indications for use as stated in the FDA summary.

Also cleared against K021497

4 other devices cite the same predicate.

  • K060992Syngo US WorkplaceSiemens Medical Solutions · 20061 recall
  • K052331Acuson Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
  • K042055Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
  • K022896CSV12 Software ViewerAcuson Corp. · 2002

More from Teratech Corp.

17 FDA decisions under this applicant name. See the company

  • K150533Terason uSmart3200T Ultrasound SystemTeratech Corp. · 2015
  • K150148Terason uSmart3300 Ultrasound SystemTeratech Corp. · 2015
  • K140773Terason USMART3300 Ultrasound SystemTeratech Corp. · 2014
  • K140834Terason USMART3400 Ultrasound SystemTeratech Corp. · 2014
  • K140524Terason USMART3200 and Benq UP200ULTRASOUND SystemTeratech Corp. · 2014

Recent decisions in IYO

The IYO category page

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  • K260313MD-6000S Bladder ScannerMEDA Co., Ltd. · 2026
  • K253452Accuro 3SRivanna Medical, Inc. · 2026
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https://510kreport.com/device/K080234 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080234: Terason Echo T/3000 Ultrasound System with Stress Echo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080234

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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