510(k) · Cleared
ClearedTringa Ultrasound Imaging System, Model 50L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pie Medical · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Dec 15, 2003 as substantially equivalent to K020112 (Pie Medical, 2002) and 1 other predicate after a 28-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Dec 15, 2003
- Review
- 28 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K944287 (1995). 12 ancestors in all, the oldest K850478 (1985). No later device cites it as a predicate yet.
- Root · 3 generations backK944287 7050 Ultrasound Imaging SystemBiosound, Inc. · 1995
- 2 generations backK981293 7200 Ultrasound Imaging SystemBiosound Esaote, Inc. · 1998
- 1 generation backK020112 50S Tringa Ultrasound Imaging SystemPie Medical · 2002
- This deviceK033604 Tringa Ultrasound Imaging System, Model 50LPie Medical · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944287 | 7050 Ultrasound Imaging System | Biosound, Inc. | 1995 | — |
| −2 | K981293 | 7200 Ultrasound Imaging System | Biosound Esaote, Inc. | 1998 | — |
| −1 | K020112 | 50S Tringa Ultrasound Imaging System | Pie Medical | 2002 | — |
| 0 (this device) | K033604 | Tringa Ultrasound Imaging System, Model 50L | Pie Medical | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 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 IYO? 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020112 | 50S Tringa Ultrasound Imaging SystemSummary page 1…fication Number: 901YO 807.92(a)(3) Predicate Device(s) Pie Medical 50S Tringa K020112 SonoSite i Look 25 K021628 Additional Substantial Equivalence Informatio… | 2002 |
| * | K021628 | Sonosite Hand-Caried Untrasound System (Powerseries)Summary page 1…e Device(s) Pie Medical 50S Tringa K020112 SonoSite i Look 25 K021628 Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 8 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 12 ancestors has a recall.
- 5 other devices also cite its predicate K020112.
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?
Pie Medical's 50L Tringa ultrasound system is to be used by or under the direction of a physician to perform general non-invasive and invasive diagnostic ultrasound imaging studies, to include: abdominal, neonatal cephalic, pediatric, peripheral vascular, small organs, intraoperative abdominal, intraoperative vascular and musculoskeletal (conventional and superficial). The system provides ultrasound guidance for freehand or biopsy guided placement of needles and catheters in vascular or other anatomical structures.
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/K033604 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033604: Tringa Ultrasound Imaging System, Model 50L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033604
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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