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 29, 2019 as substantially equivalent to K180894 (Levita Magnetics International Corp, 2018) and 1 other predicate after a 117-day review. Its family tree reaches back 3 generations to 2016. 3 later devices descend from it.
- Decided
- Apr 29, 2019
- Review
- 117 days
- Class
- Class II
- Product code
- PNL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to DEN150007 (2016). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backDEN150007 Magnetic Surgical SystemLevita Magnetics International Corp · 2016
- 2 generations backK171429 Magnetic Surgical SystemLevita Magnetics International Corp · 2017
- 1 generation backK180894 Magnetic Surgical SystemLevita Magnetics International Corp · 2018
- This deviceK190006 Magnetic Surgical SystemLevita Magnetics International Corp · 2019
- Descendant · cites it directly · 2 of its ownK191762 Magnetic Surgical SystemLevita Magnetics International Corp · 2020
- Descendant · 2 generations on · 1 of its ownK250746 Magnetic Surgical SystemLevita Magnetics International Corp · 2025
- Descendant · 3 generations on · 0 of its ownK252435 Magnetic Surgical SystemLevita Magnetics International Corp · 2025
Most influential descendants
Showing 3 of 3 · See all- K191762Magnetic Surgical SystemLevita Magnetics International Corp · 2020 · cites it directly2descendants
- K250746Magnetic Surgical SystemLevita Magnetics International Corp · 2025 · 2 generations on1descendant
- K252435Magnetic Surgical SystemLevita Magnetics International Corp · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN150007 | Magnetic Surgical System | Levita Magnetics International Corp | 2016 | — |
| −2 | K171429 | Magnetic Surgical System | Levita Magnetics International Corp | 2017 | — |
| −1 | K180894 | Magnetic Surgical System | Levita Magnetics International Corp | 2018 | — |
| 0 (this device) | K190006 | Magnetic Surgical System | Levita Magnetics International Corp | 2019 | — |
| +1 | K191762 | Magnetic Surgical System | Levita Magnetics International Corp | 2020 | — |
| +2 | K250746 | Magnetic Surgical System | Levita Magnetics International Corp | 2025 | — |
| +3 | K252435 | Magnetic Surgical System | Levita Magnetics International Corp | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K180894 | Magnetic Surgical SystemSummary page 4…egulation Name: Magnetic Surgical Instrument System Device Class: II Product Code: PNL Predicate Devices: Levita Magnetic Surgical System, K180894 (primary predicate) Levita Magnetic Surgical System, DEN150007 (secondary predicate) Date Prepared: April 26, 2019 Device Descr… | 2018 |
| * | DEN150007 | Magnetic Surgical SystemSummary page 4…evice Class: II Product Code: PNL Predicate Devices: Levita Magnetic Surgical System, K180894 (primary predicate) Levita Magnetic Surgical System, DEN150007 (secondary predicate) Date Prepared: April 26, 2019 Device Description: The Levita Magnetic Surgical System is composed of two… | 2016 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191762 | Magnetic Surgical System | 2020 | 2 |
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 3 years and passes through 1 company; a new generation was cleared every 12 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K191762 (Levita Magnetics International Corp, 2020) has gone furthest, with 2 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. 2019, 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, and the prostate and periprostatic tissue in prostatectomy 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/K190006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190006: 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/K190006
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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