510(k) · Cleared
ClearedVENUE 40
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Sep 23, 2011 as substantially equivalent to K102113 (Ge Medical Systems China Co., Ltd., 2010) and 2 other predicates after a 60-day review. Its family tree reaches back 10 generations to 1987. 160 later devices descend from it.
- Decided
- Sep 23, 2011
- Review
- 60 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K863700 (1987). 15 ancestors in all. 160 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK863700 RT2800(115V)/H4008C and RT2800(220/240V)/H4008CEGeneral Electric Co. · 1987
- 6 generations between
- 3 generations backK091164 GE Venue 40, Model 5324338Ge Medical Systems China Co., Ltd. · 2009
- 2 generations backK091374 GE Logiq I/E & Vivid E Compact UltrasoundGe Medical Systems China Co., Ltd. · 2009
- 1 generation backK102113 GE Venue 40 Compact Diagnostic UltrasoundGe Medical Systems China Co., Ltd. · 2010
- This deviceK112122 VENUE 40GE Healthcare · 2011
- Descendant · cites it directly · 99 of its ownK142466 UGEO PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- Descendant · 2 generations on · 98 of its ownK143264 H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- Descendant · 2 generations on · 97 of its ownK150478 A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- Descendant · 2 generations on · 96 of its ownK151663 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- Descendant · 3 generations on · 90 of its ownK152962 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
Show all 10 generations
- Root · 10 generations backK863700 RT2800(115V)/H4008C and RT2800(220/240V)/H4008CEGeneral Electric Co. · 1987
- 9 generations backK953752 RT55 Diagnostic Ultrasound SystemGeneral Electric Co. · 1996
- 8 generations backK012560 GE Logiq A100 MP, Model 2272413General Electric Co. · 2001
- 7 generations backK014206 LogiqbookGeneral Electric Co. · 2002 · Recalled
- 6 generations backK032477 GE Logiq BookGeneral Electric Co. · 2003
- 5 generations backK050126 GE Logiq TwinGeneral Electric Co. · 2005
- 4 generations backK072797 GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE…General Electric Co. · 2007
- 3 generations backK091164 GE Venue 40, Model 5324338Ge Medical Systems China Co., Ltd. · 2009
- 2 generations backK091374 GE Logiq I/E & Vivid E Compact UltrasoundGe Medical Systems China Co., Ltd. · 2009
- 1 generation backK102113 GE Venue 40 Compact Diagnostic UltrasoundGe Medical Systems China Co., Ltd. · 2010
- This deviceK112122 VENUE 40GE Healthcare · 2011
Showing 5 of 160 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 160 · See all- K142466UGEO PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · cites it directly99descendants
- K143264H60 V2.00 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · 2 generations on98descendants
- K150478A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015 · 2 generations on97descendants
- K151663RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015 · 2 generations on96descendants
- K152962HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015 · 3 generations on90descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K863700 | RT2800(115V)/H4008C and RT2800(220/240V)/H4008CE | General Electric Co. | 1987 | — |
| −9 | K953752 | RT55 Diagnostic Ultrasound System | General Electric Co. | 1996 | — |
| −8 | K012560 | GE Logiq A100 MP, Model 2272413 | General Electric Co. | 2001 | — |
| −7 | K014206 | Logiqbook | General Electric Co. | 2002 | 1 |
| −6 | K032477 | GE Logiq Book | General Electric Co. | 2003 | — |
| −5 | K050126 | GE Logiq Twin | General Electric Co. | 2005 | — |
| −4 | K072797 | GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E… | General Electric Co. | 2007 | — |
| −3 | K091164 | GE Venue 40, Model 5324338 | Ge Medical Systems China Co., Ltd. | 2009 | — |
| −2 | K091374 | GE Logiq I/E & Vivid E Compact Ultrasound | Ge Medical Systems China Co., Ltd. | 2009 | — |
| −1 | K102113 | GE Venue 40 Compact Diagnostic Ultrasound | Ge Medical Systems China Co., Ltd. | 2010 | — |
| 0 (this device) | K112122 | VENUE 40 | GE Healthcare | 2011 | — |
| +1 | K142466 | UGEO PT60A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| +2 | K143264 | H60 V2.00 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| +2 | K150478 | A35 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| +2 | K151663 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| +3 | K152962 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2016 | 8 | 0 |
| 2017 | 14 | 0 |
| 2018 | 16 | 0 |
| 2019 | 14 | 0 |
| 2020 | 18 | 0 |
| 2021 | 15 | 0 |
| 2022 | 20 | 0 |
| 2023 | 11 | 0 |
| 2024 | 13 | 0 |
| 2025 | 13 | 0 |
| 2026 | 9 | 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 IYN? 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? (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 |
|---|---|---|---|
| * | K102113 | GE Venue 40 Compact Diagnostic UltrasoundSummary page 1…0, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-I TX Predicate Device(s): Venue 40 - K 1021 13 LOGIQ i/e & Vivid e - K1 02256 Logiq P5 - K060993 Device Descr… | 2010 |
| * | K102256 | GE Logiq I/E & Vivid E Compact Diagnostic UltrasoundSummary page 1…Transducer, 21 CFR 892.1570, 90-I TX Predicate Device(s): Venue 40 - K 1021 13 LOGIQ i/e & Vivid e - K1 02256 Logiq P5 - K060993 Device Description: The Venue 40 device is… | 2010 |
| * | K060993 | GE Logiq P5 and A5Summary page 1…90-I TX Predicate Device(s): Venue 40 - K 1021 13 LOGIQ i/e & Vivid e - K1 02256 Logiq P5 - K060993 Device Description: The Venue 40 device is a compact and extremely portable… | 2006 |
What descends from it? (160)
See all 1602 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 24 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K142466 (Samsung Medison Co., Ltd., 2014) has gone furthest, with 99 descendants of its own.
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. 2011, 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 Venue 40 is intended for ultrasound imaging, measurement and analysis of the
human body for multiple clinical applications including: Fetal/OB; Abdominal (GYN &
Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult
Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal
Conventional & Superficial; Transvaginal; Intraoperative (abdominal, thoracic and
peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of
interventional procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K112122 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112122: VENUE 40.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112122
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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