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 Apr 1, 2020 as substantially equivalent to K190006 (Levita Magnetics International Corp, 2019) after a 275-day review. Its family tree reaches back 4 generations to 2016. 2 later devices descend from it.
- Decided
- Apr 1, 2020
- Review
- 275 days
- Class
- Class II
- Product code
- PNL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN150007 (2016). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backDEN150007 Magnetic Surgical SystemLevita Magnetics International Corp · 2016
- 3 generations backK171429 Magnetic Surgical SystemLevita Magnetics International Corp · 2017
- 2 generations backK180894 Magnetic Surgical SystemLevita Magnetics International Corp · 2018
- 1 generation backK190006 Magnetic Surgical SystemLevita Magnetics International Corp · 2019
- This deviceK191762 Magnetic Surgical SystemLevita Magnetics International Corp · 2020
- Descendant · cites it directly · 1 of its ownK250746 Magnetic Surgical SystemLevita Magnetics International Corp · 2025
- Descendant · 2 generations on · 0 of its ownK252435 Magnetic Surgical SystemLevita Magnetics International Corp · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN150007 | Magnetic Surgical System | Levita Magnetics International Corp | 2016 | — |
| −3 | K171429 | Magnetic Surgical System | Levita Magnetics International Corp | 2017 | — |
| −2 | K180894 | Magnetic Surgical System | Levita Magnetics International Corp | 2018 | — |
| −1 | K190006 | Magnetic Surgical System | Levita Magnetics International Corp | 2019 | — |
| 0 (this device) | K191762 | Magnetic Surgical System | Levita Magnetics International Corp | 2020 | — |
| +1 | K250746 | Magnetic Surgical System | Levita Magnetics International Corp | 2025 | — |
| +2 | K252435 | Magnetic Surgical System | Levita Magnetics International Corp | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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 |
|---|---|---|---|
| * | K190006 | Magnetic Surgical SystemSummary page 5…ral & Plastic Surgery Device Type: Magnetic Surgical Instrument System Device Class: II Product Code: PNL Predicate Devices: Levita Magnetic Surgical System, K190006 Date Prepared: April 8, 2020 Device Description: The Levita Magnetic Surgical System is composed of two hand-held instruments,… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250746 | Magnetic Surgical System | 2025 | 1 |
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 4 years and passes through 1 company; a new generation was cleared every 12 months on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K250746 (Levita Magnetics International Corp, 2025) has gone furthest, with 1 descendant 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. 2020, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191762: 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/K191762
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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