510(k) · Cleared
Recalled · Class II · 2026MOLLI 2 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · NEU Marker, Radiographic, Implantable
Cleared on Dec 31, 2025 as substantially equivalent to K240042 (Molli Surgical, Inc., 2024) after a 27-day review. Its family tree reaches back 13 generations to 2003. It has been recalled once.
- Decided
- Dec 31, 2025
- Review
- 27 days
- Class
- Class II
- Product code
- NEU
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 13 generations to K023694 (2003). 28 ancestors in all, the oldest K970817 (1997). No later device cites it as a predicate yet.
- Root · 13 generations backK023694 Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy…Biopsy Sciences, LLC · 2003
- 9 generations between
- 3 generations backK223107 MOLLI 2Molli Surgical, Inc. · 2023
- 2 generations backK231579 MOLLI 2Molli Surgical, Inc. · 2023 · Recalled
- 1 generation backK240042 MOLLI 2 SystemMolli Surgical, Inc. · 2024
- This deviceK253888 MOLLI 2 SystemStryker Endoscopy · 2025
Show all 13 generations
- Root · 13 generations backK023694 Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy…Biopsy Sciences, LLC · 2003
- 12 generations backK051421 Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc. · 2005
- 11 generations backK053518 Interv Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc. · 2006
- 10 generations backK060769 Hydromark Biopsy Site MarkerBiopsy Sciences, LLC · 2006
- 9 generations backK083006 Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerBiopsy Sciences, LLC · 2009
- 8 generations backK090501 Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models…Biopsy Sciences, LLC · 2009
- 7 generations backK120804 Cianna Medical Tissue Marker and Delivery SystemCianna Medical · 2013
- 6 generations backK153044 Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd., · 2016
- 5 generations backK163541 Magseed Magnetic Marker SystemEndomagnetics Ltd., · 2017
- 4 generations backK210600 MOLLIMolli Surgical, Inc. · 2021
- 3 generations backK223107 MOLLI 2Molli Surgical, Inc. · 2023
- 2 generations backK231579 MOLLI 2Molli Surgical, Inc. · 2023 · Recalled
- 1 generation backK240042 MOLLI 2 SystemMolli Surgical, Inc. · 2024
- This deviceK253888 MOLLI 2 SystemStryker Endoscopy · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K023694 | Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy Site Marker | Biopsy Sciences, LLC | 2003 | — |
| −12 | K051421 | Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium Anchor | Medical Device Technologies, Inc. | 2005 | — |
| −11 | K053518 | Interv Brand V-Mark Breast Biopsy Site Marker with Titanium Anchor | Medical Device Technologies, Inc. | 2006 | — |
| −10 | K060769 | Hydromark Biopsy Site Marker | Biopsy Sciences, LLC | 2006 | — |
| −9 | K083006 | Biopsy Sciences, Inc., Hydromark Breast Biopsy Site Marker | Biopsy Sciences, LLC | 2009 | — |
| −8 | K090501 | Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1… | Biopsy Sciences, LLC | 2009 | — |
| −7 | K120804 | Cianna Medical Tissue Marker and Delivery System | Cianna Medical | 2013 | — |
| −6 | K153044 | Sentimag System, Sentimark Magnetic Marker Systerm | Endomagnetics Ltd., | 2016 | — |
| −5 | K163541 | Magseed Magnetic Marker System | Endomagnetics Ltd., | 2017 | — |
| −4 | K210600 | MOLLI | Molli Surgical, Inc. | 2021 | — |
| −3 | K223107 | MOLLI 2 | Molli Surgical, Inc. | 2023 | — |
| −2 | K231579 | MOLLI 2 | Molli Surgical, Inc. | 2023 | 1 |
| −1 | K240042 | MOLLI 2 System | Molli Surgical, Inc. | 2024 | — |
| 0 (this device) | K253888 | MOLLI 2 System | Stryker Endoscopy | 2025 | — |
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 |
| 2018 | 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 NEU? 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 NEU device
- #1 K240042 MOLLI 2 Systemscore 14.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K240042 | MOLLI 2 SystemSummary page 5…# Predicate Trade Name Product Code K240042 MOLLI 2 System NEU Device Description Summary: The MOLLI Systems (MOL… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 21, 2026 | Class II | Z-1427-2026 | Under Investigation by firm | Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 28 ancestors have a recall of any class.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · NEU
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEU
99in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEU
2in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NEU
411in 2025
MAUDE reports naming product code NEU, 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 | 4 | 94 | 0 | 5 |
| 2008 | 7 | 107 | 0 | 5 |
| 2009 | 4 | 70 | 0 | 30 |
| 2010 | 5 | 69 | 0 | 12 |
| 2011 | 3 | 145 | 1 | 18 |
| 2012 | 3 | 120 | 0 | 54 |
| 2013 | 7 | 49 | 0 | 60 |
| 2014 | 3 | 48 | 0 | 38 |
| 2015 | 7 | 111 | 0 | 120 |
| 2016 | 2 | — | 0 | 56 |
| 2017 | 4 | 115 | 1 | 69 |
| 2018 | 8 | 89 | 0 | 66 |
| 2019 | 5 | 149 | 0 | 58 |
| 2020 | 3 | 169 | 0 | 45 |
| 2021 | 3 | 46 | 0 | 82 |
| 2022 | 2 | — | 1 | 100 |
| 2023 | 4 | 136 | 0 | 142 |
| 2024 | 10 | 267 | 2 (1) | 247 |
| 2025 | 5 | 99 | 2 | 411 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. The MOLLI Marker can be implanted for greater than 30 days. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (MOLLI Systems (MOLLI System and MOLLI 2 System)), the MOLLI Marker is located and surgically removed with the target tissue.
The MOLLI Systems (MOLLI System and MOLLI 2 System) are intended only for the non-imaging detection and localization of the MOLLI Marker that has been implanted in a site intended for surgical removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253888 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253888: MOLLI 2 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253888
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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