510(k) · Cleared
ClearedTetrad 2300 E/U Ultrasoung Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tetra Corp. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Mar 15, 1996 after a 444-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 of the 112 devices in its family, counting itself, have a Class I recall. 111 later devices descend from it.
- Decided
- Mar 15, 1996
- Review
- 444 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 0
111 later devices descend from it, 2 citing it directly. 2 of the 112 devices in this family, counting this one, have a Class I recall.
- This deviceK946277 Tetrad 2300 E/U Ultrasoung Imaging SystemTetra Corp. · 1996
- Descendant · cites it directly · 109 of its ownK992505 Teratech, Model 2000 Imaging ImagingTeratech Corp. · 1999
- Descendant · 2 generations on · 106 of its ownK070907 Interson Usb Ultrasound Probe SystemRegulatory Management Services · 2007
- Descendant · 3 generations on · 103 of its ownK102153 Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011
- Descendant · 3 generations on · 87 of its ownK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
- Descendant · 4 generations on · 79 of its ownK152899 Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · Recalled
Showing 5 of 111 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 111 · See all- K992505Teratech, Model 2000 Imaging ImagingTeratech Corp. · 1999 · cites it directly109descendants
- K070907Interson Usb Ultrasound Probe SystemRegulatory Management Services · 2007 · 2 generations on106descendants
- K102153Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011 · 3 generations on103descendants
- K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · 3 generations on87descendants
- K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · 4 generations on79descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946277 | Tetrad 2300 E/U Ultrasoung Imaging System | Tetra Corp. | 1996 | — |
| +1 | K992505 | Teratech, Model 2000 Imaging Imaging | Teratech Corp. | 1999 | — |
| +2 | K070907 | Interson Usb Ultrasound Probe System | Regulatory Management Services | 2007 | — |
| +3 | K102153 | Mobius Ultrasound Imaging System | Mobisante, Inc. | 2011 | — |
| +3 | K133833 | Nuvis Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2014 | 3 |
| +4 | K152899 | Philips Lumify Diagnostic Ultrasound System | Philips Healthcare, Inc. | 2015 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 8 | 0 |
| 2021 | 12 | 0 |
| 2022 | 9 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 15 | 2 |
| 2026 | 16 | 0 |
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.
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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (111)
See all 1112 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)
No FDA recall names this device.
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?
- Of its descendants, K992505 (Teratech Corp., 1999) has gone furthest, with 109 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.
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) | — |
https://510kreport.com/device/K946277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K946277: Tetrad 2300 E/U Ultrasoung Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K946277
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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