510(k) · Cleared
ClearedSurgi-Vision Esophageal Stylet Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgi-Vision, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Mar 14, 2000 as substantially equivalent to K992193 (Surgi-Vision, Inc., 1999) after a 75-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- Mar 14, 2000
- Review
- 75 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K952232 (1995). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK952232 Mrinnervu Disposable Endorectal Colon Coil, Catalong NO. PCC-15Medrad, Inc. · 1995
- 1 generation backK992193 Endo-Esophageal MR CoilSurgi-Vision, Inc. · 1999
- This deviceK994436 Surgi-Vision Esophageal Stylet CoilSurgi-Vision, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK020790 Intercept Esophageal Internal MR Coil, Intercept Urethral Microcoil…Surgi-Vision, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK020495 Intercept Esophageal Internal MR Coil, Intercept Urethral Internal…Surgi-Vision, Inc. · 2002
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 |
|---|---|---|---|---|---|
| −2 | K952232 | Mrinnervu Disposable Endorectal Colon Coil, Catalong NO. PCC-15 | Medrad, Inc. | 1995 | — |
| −1 | K992193 | Endo-Esophageal MR Coil | Surgi-Vision, Inc. | 1999 | — |
| 0 (this device) | K994436 | Surgi-Vision Esophageal Stylet Coil | Surgi-Vision, Inc. | 2000 | — |
| +1 | K020790 | Intercept Esophageal Internal MR Coil, Intercept Urethral Microcoil, and… | Surgi-Vision, Inc. | 2002 | — |
| +1 | K020495 | Intercept Esophageal Internal MR Coil, Intercept Urethral Internal MR Coil… | Surgi-Vision, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 MOS? 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 MOS device
- #1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 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 |
|---|---|---|---|
| * | K992193 | Endo-Esophageal MR CoilSummary page 1…eal Stylet Coil is substantially equivalent to the Surgi-Vision Endo-Esophageal MRI Coil, which was cleared for marketing on September 3, 1999, in premarket notification K992193. B. DEVICE DESCRIPTION The Surgi-Vision Esophageal Stylet Coil is a specialty coil for use in MRI imaging of the anatomical reg… | 1999 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K020790 (Surgi-Vision, Inc., 2002) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 2025
MAUDE reports naming product code MOS, 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 | 16 | 19 | 0 | 4 |
| 2008 | 19 | 33 | 2 | 2 |
| 2009 | 10 | 43 | 0 | 5 |
| 2010 | 16 | 78 | 1 | 13 |
| 2011 | 25 | 57 | 0 | 7 |
| 2012 | 15 | 49 | 1 | 12 |
| 2013 | 7 | 87 | 0 | 10 |
| 2014 | 12 | 60 | 0 | 4 |
| 2015 | 6 | 58 | 2 | 5 |
| 2016 | 11 | 42 | 0 | 7 |
| 2017 | 9 | 63 | 0 | 9 |
| 2018 | 10 | 30 | 0 | 7 |
| 2019 | 3 | 178 | 8 | 8 |
| 2020 | 5 | 51 | 1 | 2 |
| 2021 | 4 | 41 | 0 | 3 |
| 2022 | 11 | 79 | 0 | 5 |
| 2023 | 10 | 59 | 0 | 4 |
| 2024 | 10 | 39 | 13 | 8 |
| 2025 | 3 | 59 | 0 | 2 |
| 2026 | 10 | 45 | 0 | — |
What is it indicated for?
The Surgi-Vision Esophageal Stylet Coil is recommended for high-resolution Magnetic Resonance Imaging of the human esophagus. The single use, disposable coil has been designed to be inserted in the esophagus of the patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the esophagus. The unique coil shape facilitates orientation of the coil to the anatomy. This product is to be used with a 1.5T MRI machine.
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/K994436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994436: Surgi-Vision Esophageal Stylet Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994436
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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