510(k) · Cleared
ClearedMagnetic Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Levita Magnetics International Corp · PNL Magnetic Surgical System
Cleared on Sep 26, 2025 as substantially equivalent to K250746 (Levita Magnetics International Corp, 2025) after a 56-day review. Its family tree reaches back 6 generations to 2016.
- Decided
- Sep 26, 2025
- Review
- 56 days
- Class
- Class II
- Product code
- PNL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN150007 (2016). No later device cites it as a predicate yet.
- Root · 6 generations backDEN150007 Magnetic Surgical SystemLevita Magnetics International Corp · 2016
- 5 generations backK171429 Magnetic Surgical SystemLevita Magnetics International Corp · 2017
- 4 generations backK180894 Magnetic Surgical SystemLevita Magnetics International Corp · 2018
- 3 generations backK190006 Magnetic Surgical SystemLevita Magnetics International Corp · 2019
- 2 generations backK191762 Magnetic Surgical SystemLevita Magnetics International Corp · 2020
- 1 generation backK250746 Magnetic Surgical SystemLevita Magnetics International Corp · 2025
- This deviceK252435 Magnetic Surgical SystemLevita Magnetics International Corp · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN150007 | Magnetic Surgical System | Levita Magnetics International Corp | 2016 | — |
| −5 | K171429 | Magnetic Surgical System | Levita Magnetics International Corp | 2017 | — |
| −4 | K180894 | Magnetic Surgical System | Levita Magnetics International Corp | 2018 | — |
| −3 | K190006 | Magnetic Surgical System | Levita Magnetics International Corp | 2019 | — |
| −2 | K191762 | Magnetic Surgical System | Levita Magnetics International Corp | 2020 | — |
| −1 | K250746 | Magnetic Surgical System | Levita Magnetics International Corp | 2025 | — |
| 0 (this device) | K252435 | Magnetic Surgical System | Levita Magnetics International Corp | 2025 | — |
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 PNL? 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 PNL device
- #1 K250746 Magnetic Surgical Systemscore 13.7 · 5 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 |
|---|---|---|---|
| * | K250746 | Magnetic Surgical SystemSummary page 5…cal System 878.4815 PNL | Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) 21 CFR 807.92(a)(3) Product Code K250746 Levita Magnetic Surgical System PNL Device Description Summary 21 CFR 807.92(a)(4) Shaft. Magnetic The Magnetic Surgical S… | 2025 |
| † | DEN150007 | Magnetic Surgical System | 2016 |
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 9 years and passes through 1 company; a new generation was cleared every 12 months on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All PNL devicesPNL Magnetic Surgical System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PNL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PNL
Too few PNL 510(k)s in any year since 2007 to give a median.
Recalls per year · PNL
No recall names PNL since 2007.
Adverse event reports per year · PNL
No MAUDE report names PNL since 2007.
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 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Magnetic Surgical System is indicated for use in patients within a BMI range of 20 to 60 kg/m2 and designed to grasp and retract soft tissues and organs to facilitate access and visualization of the surgical site for the following: -The body and fundus of the gallbladder in laparoscopic cholecystectomy procedures -The liver in bariatric procedures -The prostate and periprostatic tissue in prostatectomy procedures -The colon, rectum, and…
Read the full statement (184 words)
The Magnetic Surgical System is indicated for use in patients within a BMI range of 20 to 60 kg/m2 and designed to grasp and retract soft tissues and organs to facilitate access and visualization of the surgical site for the following:
-The body and fundus of the gallbladder in laparoscopic cholecystectomy procedures
-The liver in bariatric procedures
-The prostate and periprostatic tissue in prostatectomy procedures
-The colon, rectum, and pericolorectal tissue in colorectal procedures
The Grasper Tip 12.5 is indicated for use in patients within a BMI range of 20 to 60 kg/m2 and designed to grasp and retract soft tissues and organs to facilitate access and visualization of the surgical site for the following
-The pillar of the diaphragm and peripillar tissue in bariatric or hiatal hernia procedures
Pediatric use:
The Magnetic Surgical System is indicated for use in adolescents (12-21) within a BMI range of 20 to 34 kg/m2 and designed to grasp and retract soft tissues and organs to facilitate access and visualization of the surgical site for the following:
-The body and fundus of the gallbladder in laparoscopic cholecystectomy procedures
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/K252435 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252435: Magnetic Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252435
Report an extraction error
Are you the manufacturer?
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