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 Jun 7, 2025 as substantially equivalent to K191762 (Levita Magnetics International Corp, 2020) after an 87-day review. Its family tree reaches back 5 generations to 2016. 1 later device descends from it.
- Decided
- Jun 7, 2025
- Review
- 87 days
- Class
- Class II
- Product code
- PNL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN150007 (2016). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backDEN150007 Magnetic Surgical SystemLevita Magnetics International Corp · 2016
- 4 generations backK171429 Magnetic Surgical SystemLevita Magnetics International Corp · 2017
- 3 generations backK180894 Magnetic Surgical SystemLevita Magnetics International Corp · 2018
- 2 generations backK190006 Magnetic Surgical SystemLevita Magnetics International Corp · 2019
- 1 generation backK191762 Magnetic Surgical SystemLevita Magnetics International Corp · 2020
- This deviceK250746 Magnetic Surgical SystemLevita Magnetics International Corp · 2025
- Descendant · cites it directly · 0 of its ownK252435 Magnetic Surgical SystemLevita Magnetics International Corp · 2025
Most influential descendants
Showing 1 of 1 · See all- K252435Magnetic Surgical SystemLevita Magnetics International Corp · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN150007 | Magnetic Surgical System | Levita Magnetics International Corp | 2016 | — |
| −4 | K171429 | Magnetic Surgical System | Levita Magnetics International Corp | 2017 | — |
| −3 | K180894 | Magnetic Surgical System | Levita Magnetics International Corp | 2018 | — |
| −2 | K190006 | Magnetic Surgical System | Levita Magnetics International Corp | 2019 | — |
| −1 | K191762 | Magnetic Surgical System | Levita Magnetics International Corp | 2020 | — |
| 0 (this device) | K250746 | Magnetic Surgical System | Levita Magnetics International Corp | 2025 | — |
| +1 | K252435 | Magnetic Surgical System | Levita Magnetics International Corp | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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 K252435 Magnetic Surgical Systemscore 11.6 · 6 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 |
|---|---|---|---|
| * | K191762 | Magnetic Surgical SystemSummary page 5…r 878.4815 Product Code(s) PNL Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K191762 Levita Magnetic Surgical System PNL Device Description Summary 21 CFR 807.92(a)(4)… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252435 | Magnetic Surgical System | 2025 | 0 |
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 5 ancestors has a recall.
- Of its descendants, K252435 (Levita Magnetics International Corp, 2025) has gone furthest, with 0 descendants of its own.
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 Levita Magnetic Surgical System is designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures; the liver in bariatric procedures; the pillar of the diaphragm and peripillar tissue in bariatric or hiatal hernia procedures; the prostate and periprostatic tissue in prostatectomy procedures; and the colon, rectum, and pericolorectal tissue in colorectal procedures to facilitate access and…
Read the full statement (131 words)
The Levita Magnetic Surgical System is designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures; the liver in bariatric procedures; the pillar of the diaphragm and peripillar tissue in bariatric or hiatal hernia procedures; the prostate and periprostatic tissue in prostatectomy procedures; and the colon, rectum, and pericolorectal tissue in colorectal procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients with a BMI range of 20-60-kg/m2.
The Grasper Tip, 12.5 is designed to grasp and retract the pillar of the diaphragm and peripillar tissue in bariatric or hiatal hernia procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients with a BMI range of 20-60 kg/m2.
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/K250746 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250746: Magnetic Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250746
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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