510(k) · Cleared
ClearedKapp Bari-Ring, Model KS-BR-2005
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kapp Surgical Instrument, Inc. · NEU Marker, Radiographic, Implantable
Cleared on Jan 13, 2006 as substantially equivalent to K971966 (Med-Edge, Inc., 1998) and 1 other predicate after a 332-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.
- Decided
- Jan 13, 2006
- Review
- 332 days
- Class
- Class II
- Product code
- NEU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K895369 (1989). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK895369 Voss Graft MarkerVoss Medical Products · 1989
- This deviceK050384 Kapp Bari-Ring, Model KS-BR-2005Kapp Surgical Instrument, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK072216 Kapp Bari-Ring Endoscopic Marker, Model K-9536Kapp Surgical Instrument, Inc. · 2007 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K072216Kapp Bari-Ring Endoscopic Marker, Model K-9536Kapp Surgical Instrument, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895369 | Voss Graft Marker | Voss Medical Products | 1989 | — |
| 0 (this device) | K050384 | Kapp Bari-Ring, Model KS-BR-2005 | Kapp Surgical Instrument, Inc. | 2006 | — |
| +1 | K072216 | Kapp Bari-Ring Endoscopic Marker, Model K-9536 | Kapp Surgical Instrument, Inc. | 2007 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 NEU? 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 NEU device
- #1 K240042 MOLLI 2 Systemscore 14.4 · 12 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 |
|---|---|---|---|
| * | K971966 | Coronary Vein Graft Tag MarkerSummary page 1…ostic means (contrast or endoscopy) . Comparison to the Predicate Devices: The legally marketed predicate devices to which this device is substantially equivalent are: K97 1966, Med-Edge Coronary Vein Graft Tag Marker K895369, Voss Graft Marker - 4… | 1998 |
| * | K895369 | Voss Graft MarkerSummary page 1…to the Predicate Devices: The legally marketed predicate devices to which this device is substantially equivalent are: K97 1966, Med-Edge Coronary Vein Graft Tag Marker K895369, Voss Graft Marker - 4 -… | 1989 |
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 |
|---|---|---|---|
| K072216 | Kapp Bari-Ring Endoscopic Marker, Model K-9536 | 2007 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K072216 (Kapp Surgical Instrument, Inc., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NEU
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEU
99in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEU
2in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NEU
411in 2025
MAUDE reports naming product code NEU, 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 | 4 | 94 | 0 | 5 |
| 2008 | 7 | 107 | 0 | 5 |
| 2009 | 4 | 70 | 0 | 30 |
| 2010 | 5 | 69 | 0 | 12 |
| 2011 | 3 | 145 | 1 | 18 |
| 2012 | 3 | 120 | 0 | 54 |
| 2013 | 7 | 49 | 0 | 60 |
| 2014 | 3 | 48 | 0 | 38 |
| 2015 | 7 | 111 | 0 | 120 |
| 2016 | 2 | — | 0 | 56 |
| 2017 | 4 | 115 | 1 | 69 |
| 2018 | 8 | 89 | 0 | 66 |
| 2019 | 5 | 149 | 0 | 58 |
| 2020 | 3 | 169 | 0 | 45 |
| 2021 | 3 | 46 | 0 | 82 |
| 2022 | 2 | — | 1 | 100 |
| 2023 | 4 | 136 | 0 | 142 |
| 2024 | 10 | 267 | 2 (1) | 247 |
| 2025 | 5 | 99 | 2 | 411 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
The KAPP Bari-Ring Endoscopic Marker is intended to be used to radiographically (limited to x-ray) mark the site of gastropexy performed during bariatric or other surgical procedures, especially in those procedures where the stomach is not accessible by other diagnostic means (contrast or endoscopy)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050384 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050384: Kapp Bari-Ring, Model KS-BR-2005.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050384
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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