510(k) · Cleared
ClearedTeratech, Model 2000 Imaging Imaging
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teratech Corp. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Nov 10, 1999 as substantially equivalent to K903603 (Advanced Technology Laboratories, Inc., 1991) and 2 other predicates after a 106-day review. Its family tree reaches back 1 generation to 1991. 2 of the 113 devices in its family, counting itself, have a Class I recall. 109 later devices descend from it.
- Decided
- Nov 10, 1999
- Review
- 106 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K903603 (1991). 3 ancestors in all. 109 later devices descend from it, 2 citing it directly. 2 of the 113 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK903603 Ultramark 9 Ultrasound System (UM 9)Advanced Technology Laboratories, Inc. · 1991
- This deviceK992505 Teratech, Model 2000 Imaging ImagingTeratech Corp. · 1999
- Descendant · cites it directly · 106 of its ownK070907 Interson Usb Ultrasound Probe SystemRegulatory Management Services · 2007
- Descendant · 2 generations on · 103 of its ownK102153 Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011
- Descendant · 2 generations on · 87 of its ownK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 79 of its ownK152899 Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · Recalled
- Descendant · 4 generations on · 43 of its ownK162549 Lumify Ultrasound SystemPhilips Health Care · 2016 · Recalled
Showing 5 of 109 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 109 · See all- K070907Interson Usb Ultrasound Probe SystemRegulatory Management Services · 2007 · cites it directly106descendants
- K102153Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011 · 2 generations on103descendants
- K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · 2 generations on87descendants
- K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · 3 generations on79descendants
- K162549Lumify Ultrasound SystemPhilips Health Care · 2016 · 4 generations on43descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903603 | Ultramark 9 Ultrasound System (UM 9) | Advanced Technology Laboratories, Inc. | 1991 | — |
| 0 (this device) | K992505 | Teratech, Model 2000 Imaging Imaging | Teratech Corp. | 1999 | — |
| +1 | K070907 | Interson Usb Ultrasound Probe System | Regulatory Management Services | 2007 | — |
| +2 | K102153 | Mobius Ultrasound Imaging System | Mobisante, Inc. | 2011 | — |
| +2 | K133833 | Nuvis Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2014 | 3 |
| +3 | K152899 | Philips Lumify Diagnostic Ultrasound System | Philips Healthcare, Inc. | 2015 | 4 |
| +4 | K162549 | Lumify Ultrasound System | Philips Health Care | 2016 | 6 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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.
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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K903603 | Ultramark 9 Ultrasound System (UM 9)Summary page 1…Echo Imaging System (21 CFR 892.1560, 90-IYO) Diagnostic Ultrasound Transducer (21 CFR 892.1570, 90-ITX) 3. PREDICATE DEVICES ATL High-Definition Imaging UltraMark-9 (K903603) B&K 3535 (K914945) Tetrad 2300 E/U (K946277) 4. INTENDED USE The TERATECH Model 2000 is intended for abdominal, pelvic, cardia… | 1991 |
| * | K914945 | Diagnostic Ultrasound System Type 3535, ModifiedSummary page 1…m (21 CFR 892.1560, 90-IYO) Diagnostic Ultrasound Transducer (21 CFR 892.1570, 90-ITX) 3. PREDICATE DEVICES ATL High-Definition Imaging UltraMark-9 (K903603) B&K 3535 (K914945) Tetrad 2300 E/U (K946277) 4. INTENDED USE The TERATECH Model 2000 is intended for abdominal, pelvic, cardiac, peripheral vascu… | 1992 |
| * | K946277 | Tetrad 2300 E/U Ultrasoung Imaging SystemSummary page 1…) Diagnostic Ultrasound Transducer (21 CFR 892.1570, 90-ITX) 3. PREDICATE DEVICES ATL High-Definition Imaging UltraMark-9 (K903603) B&K 3535 (K914945) Tetrad 2300 E/U (K946277) 4. INTENDED USE The TERATECH Model 2000 is intended for abdominal, pelvic, cardiac, peripheral vascular, neurovascular, and fe… | 1996 |
What descends from it? (109)
See all 1092 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?
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
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:
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/K992505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992505: Teratech, Model 2000 Imaging Imaging.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992505
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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