510(k) · Cleared
ClearedTeratech Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teratech Corp. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jul 26, 2001 as substantially equivalent to K991805 (Acuson Corp., 1999) after a 13-day review. Its family tree reaches back 2 generations to 1994. 25 later devices descend from it.
- Decided
- Jul 26, 2001
- Review
- 13 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K934915 (1994). 25 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK934915 Acuson Model 2001Acuson Corp. · 1994
- 1 generation backK991805 Aspen Ultrasound with Freestyle Imaging OptionAcuson Corp. · 1999 · Recalled
- This deviceK012191 Teratech Model 2000 Handheld Ultrasound System with Doppler and…Teratech Corp. · 2001
- Descendant · cites it directly · 24 of its ownK030191 Terason Model 2000/Bas Portable Ultrasound SystemTeratech Corp. · 2003
- Descendant · 2 generations on · 13 of its ownK032333 Cryocare CS Surgical SystemEndocare, Inc. · 2003
- Descendant · 3 generations on · 12 of its ownK050347 Modification to Cryocare CS Surgical SystemEndocare, Inc. · 2005
- Descendant · 4 generations on · 9 of its ownK060279 Cryocare CS Surgical SystemEndocare, Inc. · 2006 · Recalled
- Descendant · 5 generations on · 8 of its ownK101333 Cryocare CS Surgical SystemEndocare, Inc. · 2010 · Recalled
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K030191Terason Model 2000/Bas Portable Ultrasound SystemTeratech Corp. · 2003 · cites it directly24descendants
- K032333Cryocare CS Surgical SystemEndocare, Inc. · 2003 · 2 generations on13descendants
- K050347Modification to Cryocare CS Surgical SystemEndocare, Inc. · 2005 · 3 generations on12descendants
- K060279Cryocare CS Surgical SystemEndocare, Inc. · 2006 · 4 generations on9descendants
- K101333Cryocare CS Surgical SystemEndocare, Inc. · 2010 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934915 | Acuson Model 2001 | Acuson Corp. | 1994 | — |
| −1 | K991805 | Aspen Ultrasound with Freestyle Imaging Option | Acuson Corp. | 1999 | 1 |
| 0 (this device) | K012191 | Teratech Model 2000 Handheld Ultrasound System with Doppler and Harmonic… | Teratech Corp. | 2001 | — |
| +1 | K030191 | Terason Model 2000/Bas Portable Ultrasound System | Teratech Corp. | 2003 | — |
| +2 | K032333 | Cryocare CS Surgical System | Endocare, Inc. | 2003 | — |
| +3 | K050347 | Modification to Cryocare CS Surgical System | Endocare, Inc. | 2005 | — |
| +4 | K060279 | Cryocare CS Surgical System | Endocare, Inc. | 2006 | 3 |
| +5 | K101333 | Cryocare CS Surgical System | Endocare, Inc. | 2010 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K097367 | Acuson Sequoia™ Ultrasound System and Harmonic Imaging Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K991805 | Aspen Ultrasound with Freestyle Imaging OptionSummary page 1…ic Ultrasound Transducer (21 CFR 892.1570, 90-ITX) 3. PREDICATE DEVICES Acuson Sequoia™ Ultrasound System and Harmonic Imaging (K97367) Acuson Aspen™ Ultrasound System (K991805) 4, INTENDED USE The TERATECH Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes is intended for dia… | 1999 |
What descends from it? (25)
See all 252 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 7 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K030191 (Teratech Corp., 2003) has gone furthest, with 24 descendants of its own.
- 5 other devices also cite its predicate K991805.
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) | — |
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:
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:
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/K012191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012191: Teratech Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012191
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026