510(k) · Cleared
Recalled · 2011Kapp Bari-Ring Endoscopic Marker, Model K-9536
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 Nov 9, 2007 as substantially equivalent to K050384 (Kapp Surgical Instrument, Inc., 2006) and 1 other predicate after a 92-day review. Its family tree reaches back 3 generations to 1997. It has been recalled once.
- Decided
- Nov 9, 2007
- Review
- 92 days
- Class
- Class II
- Product code
- NEU
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K970817 (1997). 10 ancestors in all, the oldest K895369 (1989). No later device cites it as a predicate yet.
- Root · 3 generations backK970817 Micromark ClipBiopsys Medical, Inc. · 1997
- 2 generations backK993785 Ultraclip Tissue MarkerInrad · 2000 · Recalled
- 1 generation backK033447 Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM…Mri Devices Corp. · 2004
- This deviceK072216 Kapp Bari-Ring Endoscopic Marker, Model K-9536Kapp Surgical Instrument, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970817 | Micromark Clip | Biopsys Medical, Inc. | 1997 | — |
| −2 | K993785 | Ultraclip Tissue Marker | Inrad | 2000 | 1 |
| −1 | K033447 | Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models… | Mri Devices Corp. | 2004 | — |
| 0 (this device) | K072216 | Kapp Bari-Ring Endoscopic Marker, Model K-9536 | Kapp Surgical Instrument, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K050384 | Kapp Bari-Ring, Model KS-BR-2005Summary page 1…Implantible name: NEU 21 CFR Part 878.4300 Legally marketed KAPP Bari-Ring Endloscopic Marker, Model KS-BR-2005, K050384 devices to which the MRI Devices Corporation ClipLoc Soft Tissue Marker, K033447 device is substantially equivalent: Descrip… | 2006 |
| * | K033447 | Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models 12370…Summary page 1…300 Legally marketed KAPP Bari-Ring Endloscopic Marker, Model KS-BR-2005, K050384 devices to which the MRI Devices Corporation ClipLoc Soft Tissue Marker, K033447 device is substantially equivalent: Description of the The KAPP Bari-Ring Endoscopic Marker consists of a nickel device:… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 24, 2011 | Not classified | Z-2753-2011 | Labeling mix-ups | During an FDA Inspection on 3/21/11 - 3/22/11 at Kapp Surgical an uncontrolled instruction for use was discovered which contained sterilization parameters which differed from the instructions contained in the device master record. Kapp… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 10 ancestors has a recall of any class.
How does its category compare?
All NEU devicesNEU Marker, Radiographic, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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/K072216 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072216: Kapp Bari-Ring Endoscopic Marker, Model K-9536.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072216
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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