510(k) · Cleared
ClearedEndo Car Compression Anastomosis Ring (Car)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Niti Medical Technologies, Ltd. · FZP Clip, Implantable
Cleared on Aug 9, 2006 as substantially equivalent to K050356 (Niti Medical Technologies, Ltd., 2005) after a 23-day review. Its family tree reaches back 12 generations to 1993. 2 of the 45 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Aug 9, 2006
- Review
- 23 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K933887 (1993). 43 ancestors in all, the oldest K771412 (1977). 1 later device descends from it, 1 citing it directly. 2 of the 45 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 8 generations between
- 3 generations backK041751 Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd. · 2004
- 2 generations backK043115 Laparoscopic Compression Anastomosis Clip (Lapcac)Niti Medical Technologies, Ltd. · 2004
- 1 generation backK050356 Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd. · 2005
- This deviceK062008 Endo Car Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK093661 ColonringNiti Surgical Solutions, Ltd. · 2011
Show all 12 generations
- Root · 12 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 11 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 10 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
- 9 generations backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
- 8 generations backK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
- 7 generations backK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
- 6 generations backK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
- 5 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- 4 generations backK033324 Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd. · 2004
- 3 generations backK041751 Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd. · 2004
- 2 generations backK043115 Laparoscopic Compression Anastomosis Clip (Lapcac)Niti Medical Technologies, Ltd. · 2004
- 1 generation backK050356 Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd. · 2005
- This deviceK062008 Endo Car Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd. · 2006
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K093661ColonringNiti Surgical Solutions, Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K933887 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1993 | — |
| −11 | K962043 | Auto Suture Modified VCS Clip Applier | United States Surgical, A Division of Tyco Healthc | 1996 | 7 |
| −10 | K994160 | Coalescent Surgical Sutured-Clip | Coalescent Surgical | 2000 | — |
| −9 | K012317 | Coalescent Surgical U-Clip | Coalescent Surgical | 2001 | — |
| −8 | K013664 | Coalescent Surgical U-Clip | Coalescent Surgical | 2002 | — |
| −7 | K021407 | Coalescent Surgical U-Clip - or Other TBD and Accessories | Coalescent Surgical | 2002 | — |
| −6 | K023125 | Coalescent U-Clip- and Accessories | Coalescent Surgical | 2002 | — |
| −5 | K024366 | Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 1 |
| −4 | K033324 | Compression Anastomosis Clip (Cac) | Niti Medical Technologies, Ltd. | 2004 | — |
| −3 | K041751 | Compression Anastomosis Clip (Cac) | Niti Medical Technologies, Ltd. | 2004 | — |
| −2 | K043115 | Laparoscopic Compression Anastomosis Clip (Lapcac) | Niti Medical Technologies, Ltd. | 2004 | — |
| −1 | K050356 | Compression Anastomosis Ring (Car) | Niti Medical Technologies, Ltd. | 2005 | — |
| 0 (this device) | K062008 | Endo Car Compression Anastomosis Ring (Car) | Niti Medical Technologies, Ltd. | 2006 | — |
| +1 | K093661 | Colonring | Niti Surgical Solutions, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 1 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 1 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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.
2 devices in this family have a Class I recall. 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 FZP device
- #1 K260677 Vessel Closure Device (VCD177213P)score 12.6 · 3 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 |
|---|---|---|---|
| * | K050356 | Compression Anastomosis Ring (Car)Summary page 2…the Division of General and Restorative Devices. Predicate Device: Compression Anastomosis Ring (CAR) (NiTi Medical Technologies Ltd.) cleared under K050356. Performance Standards: No performance standards have been established for such device under Section 514 of the Federa… | 2005 |
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 |
|---|---|---|---|
| K093661 | Colonring | 2011 | 0 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K983536Proximate Curved and Straight Intraluminal StaplersEthicon Endo-Surgery, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 112 Class I recalls
- K940967Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994 · 3 generations back · ◆ in the 1994 ancestors bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 6 months on median.
- 7 of the 43 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K093661 (Niti Surgical Solutions, Ltd., 2011) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K050356.
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FZP
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FZP
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FZP
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FZP
1,902in 2025
MAUDE reports naming product code FZP, 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 | 6 | 31 | 1 | 1,877 |
| 2008 | 4 | 23 | 6 | 981 |
| 2009 | 3 | 22 | 0 | 2,160 |
| 2010 | 6 | 47 | 1 | 2,367 |
| 2011 | 3 | 124 | 0 | 1,678 |
| 2012 | 2 | — | 1 | 1,677 |
| 2013 | 3 | 47 | 0 | 2,381 |
| 2014 | 3 | 29 | 1 | 2,320 |
| 2015 | 8 | 182 | 0 | 2,871 |
| 2016 | 5 | 72 | 2 | 1,840 |
| 2017 | 4 | 29 | 1 | 2,594 |
| 2018 | 4 | 143 | 0 | 2,718 |
| 2019 | 1 | — | 3 | 2,903 |
| 2020 | 2 | — | 1 | 1,760 |
| 2021 | 0 | — | 0 | 1,759 |
| 2022 | 3 | 227 | 0 | 1,575 |
| 2023 | 3 | 65 | 0 | 1,918 |
| 2024 | 2 | — | 0 | 2,067 |
| 2025 | 5 | 90 | 0 | 1,902 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The NiTi Compression Anastomosis Ring (CAR) is intended for use throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. Once wound strength is sufficient to maintain the anastomosis, the NiTi Compression Anastomosis Ring is passed from the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062008: Endo Car Compression Anastomosis Ring (Car).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062008
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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