510(k) · Cleared
ClearedSirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirius Medical Systems B.V. · PBY Temporary Tissue Marker
Cleared on Nov 9, 2023 as substantially equivalent to K222643 (Sirius Medical Systems B.V., 2022) after a 336-day review. Its family tree reaches back 11 generations to 2003.
- Decided
- Nov 9, 2023
- Review
- 336 days
- Class
- Class II
- Product code
- PBY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K023694 (2003). 25 ancestors in all, the oldest K970817 (1997). No later device cites it as a predicate yet.
- Root · 11 generations backK023694 Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy…Biopsy Sciences, LLC · 2003
- 7 generations between
- 3 generations backK163541 Magseed Magnetic Marker SystemEndomagnetics Ltd., · 2017
- 2 generations backK200734 Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition…Sirius Medical Systems B.V. · 2021
- 1 generation backK222643 Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition…Sirius Medical Systems B.V. · 2022
- This deviceK223682 Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition…Sirius Medical Systems B.V. · 2023
Show all 11 generations
- Root · 11 generations backK023694 Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy…Biopsy Sciences, LLC · 2003
- 10 generations backK051421 Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc. · 2005
- 9 generations backK053518 Interv Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc. · 2006
- 8 generations backK060769 Hydromark Biopsy Site MarkerBiopsy Sciences, LLC · 2006
- 7 generations backK083006 Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC · 2009
- 6 generations backK090501 Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models…Biopsy Sciences, LLC · 2009
- 5 generations backK120804 Cianna Medical Tissue Marker and Delivery SystemCianna Medical · 2013
- 4 generations backK153044 Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd., · 2016
- 3 generations backK163541 Magseed Magnetic Marker SystemEndomagnetics Ltd., · 2017
- 2 generations backK200734 Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition…Sirius Medical Systems B.V. · 2021
- 1 generation backK222643 Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition…Sirius Medical Systems B.V. · 2022
- This deviceK223682 Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition…Sirius Medical Systems B.V. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K023694 | Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy Site Marker | Biopsy Sciences, LLC | 2003 | — |
| −10 | K051421 | Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium Anchor | Medical Device Technologies, Inc. | 2005 | — |
| −9 | K053518 | Interv Brand V-Mark Breast Biopsy Site Marker with Titanium Anchor | Medical Device Technologies, Inc. | 2006 | — |
| −8 | K060769 | Hydromark Biopsy Site Marker | Biopsy Sciences, LLC | 2006 | — |
| −7 | K083006 | Biopsy Sciences, Inc., Hydromark Breast Biopsy Site Marker | Biopsy Sciences, LLC | 2009 | — |
| −6 | K090501 | Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1… | Biopsy Sciences, LLC | 2009 | — |
| −5 | K120804 | Cianna Medical Tissue Marker and Delivery System | Cianna Medical | 2013 | — |
| −4 | K153044 | Sentimag System, Sentimark Magnetic Marker Systerm | Endomagnetics Ltd., | 2016 | — |
| −3 | K163541 | Magseed Magnetic Marker System | Endomagnetics Ltd., | 2017 | — |
| −2 | K200734 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | Sirius Medical Systems B.V. | 2021 | — |
| −1 | K222643 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | Sirius Medical Systems B.V. | 2022 | — |
| 0 (this device) | K223682 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | Sirius Medical Systems B.V. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 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 PBY? 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 PBY device
- #1 K222643 Sirius Pintuition Seed, Sirius Pintuition…score 9.9 · 10 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K222643 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base UnitSummary page 5…Il General & Plastic Surgery NEU 1.3 Predicate and Reference Devices 510(k) Trade Name Number Submitter Reference Device (B) Product Primary Code Predicate (A) K222643 Sirius Pintuition Seed, Sirius Sirius PBY X Pintuition Probe, Sirius Medical Pintuition Base Unit Systems K200734 Sirius Pintuit… | 2022 |
| † | K200734 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | 2021 |
| † | K181007 | Cianna Medical SAVI Scout Reflector and SAVI Scout System | 2018 |
| † | K183400 | EnVisio Navigation Sytem | 2019 |
| † | K181692 | 5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10… | 2018 |
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 20 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 25 ancestors have a recall of any class.
How does its category compare?
All PBY devicesPBY Temporary Tissue Marker: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PBY
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PBY
Too few PBY 510(k)s in any year since 2007 to give a median.
Recalls per year · PBY
No recall names PBY since 2007.
Adverse event reports per year · PBY
1in 2024
MAUDE reports naming product code PBY, 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 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sirius Pintuition Seed is intended to be placed Percutaneously in soft tissue to mark (>30 days) a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (Sirius Pintuition Detector) the Sirius Pintuition Seed is located and surgically removed with the target tissue.
The Sirius Pintuition Detector is intended only for the non-imaging detection and localization of the Sirius Pintuition Seed that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.
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/K223682 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223682: Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223682
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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