510(k) · Cleared
ClearedSinuscan 102/Sinusprint
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ferguson Medical · LWI Ultrasound, Sinus
Cleared on Apr 16, 1997 as substantially equivalent to K874081 (Pie Data Medical BV, 1987) after a 443-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Apr 16, 1997
- Review
- 443 days
- Class
- Class II
- Product code
- LWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K874081 (1987). No later device cites it as a predicate yet.
- Root · 1 generation backK874081 EnterscanPie Data Medical BV · 1987
- This deviceK960421 Sinuscan 102/SinusprintFerguson Medical · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K874081 | Enterscan | Pie Data Medical BV | 1987 | — |
| 0 (this device) | K960421 | Sinuscan 102/Sinusprint | Ferguson Medical | 1997 | — |
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 LWI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K874081 | EnterscanSummary page 1…ary name: Sinuscan 102/Sinusprint. B. Substantial egquivalence: Various wultrasound scanners and radiographic/CT devices. Enterscan ultrasound sinus device by Pie Data, K874081. C. Device description: The Oriola Sinuscan 102/ Sinusprint is a pulsed ultrasound scanner. D. Intended use: The Oricla Sinusc… | 1987 |
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?
- Its one ancestor has no recall.
How does its category compare?
All LWI devicesLWI Ultrasound, Sinus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWI
FDA has decided no LWI device since 2007.
Median 510(k) review, days · LWI
Too few LWI 510(k)s in any year since 2007 to give a median.
Recalls per year · LWI
No recall names LWI since 2007.
Adverse event reports per year · LWI
1in 2018
MAUDE reports naming product code LWI, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Oricla Sinuscan 102/Sinusprint device is intended for use in the ultrasound detection of frontal and maxillary sinusitis.
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/K960421 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960421: Sinuscan 102/Sinusprint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960421
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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