510(k) · Cleared
ClearedTeratech Model 8IOC4, 8IOL4 & 10LAP4 Probes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teratech Corp. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Dec 13, 2004 after a 17-day review. The FDA summary names its predicate without a number. 23 later devices descend from it.
- Decided
- Dec 13, 2004
- Review
- 17 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 4 citing it directly.
- This deviceK043278 Teratech Model 8IOC4, 8IOL4 & 10LAP4 ProbesTeratech Corp. · 2004
- Descendant · cites it directly · 12 of its ownK050347 Modification to Cryocare CS Surgical SystemEndocare, Inc. · 2005
- Descendant · 2 generations on · 9 of its ownK060279 Cryocare CS Surgical SystemEndocare, Inc. · 2006 · Recalled
- Descendant · cites it directly · 8 of its ownK101333 Cryocare CS Surgical SystemEndocare, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 7 of its ownK141110 Cryocare CS Surgical SystemHealthtronics · 2015
- Descendant · cites it directly · 7 of its ownK061153 Gynesonics EC6 TransducerGynesonics, Inc. · 2006
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K050347Modification to Cryocare CS Surgical SystemEndocare, Inc. · 2005 · cites it directly12descendants
- K060279Cryocare CS Surgical SystemEndocare, Inc. · 2006 · 2 generations on9descendants
- K101333Cryocare CS Surgical SystemEndocare, Inc. · 2010 · cites it directly8descendants
- K141110Cryocare CS Surgical SystemHealthtronics · 2015 · 2 generations on7descendants
- K061153Gynesonics EC6 TransducerGynesonics, Inc. · 2006 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043278 | Teratech Model 8IOC4, 8IOL4 & 10LAP4 Probes | Teratech Corp. | 2004 | — |
| +1 | K050347 | Modification to Cryocare CS Surgical System | Endocare, Inc. | 2005 | — |
| +2 | K060279 | Cryocare CS Surgical System | Endocare, Inc. | 2006 | 3 |
| +1 | K101333 | Cryocare CS Surgical System | Endocare, Inc. | 2010 | 2 |
| +2 | K141110 | Cryocare CS Surgical System | Healthtronics | 2015 | — |
| +1 | K061153 | Gynesonics EC6 Transducer | Gynesonics, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | Philips L19-5 Named without a submission number | |
| * | — | Teratech 10V5 Named without a submission number | |
| * | — | Philips C8-4 Named without a submission number | |
| * | — | Philips LAP L9-5 Named without a submission number |
What descends from it? (23)
See all 234 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?
- Of its descendants, K050347 (Endocare, Inc., 2005) has gone furthest, with 12 descendants of its own.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: specific indications for use are tabulated in Section 4.3 of this submission.
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/K043278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043278: Teratech Model 8IOC4, 8IOL4 & 10LAP4 Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043278
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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