510(k) · Cleared
ClearedCompression 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 May 5, 2005 as substantially equivalent to K033324 (Niti Medical Technologies, Ltd., 2004) and 5 other predicates after an 80-day review. Its family tree reaches back 11 generations to 1993. 2 of the 45 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- May 5, 2005
- Review
- 80 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 11 generations to K933887 (1993). 42 ancestors in all, the oldest K771412 (1977). 2 later devices descend from it, 2 citing it directly. 2 of the 45 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 7 generations between
- 3 generations backK033324 Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd. · 2004
- 2 generations backK041751 Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd. · 2004
- 1 generation backK043115 Laparoscopic Compression Anastomosis Clip (Lapcac)Niti Medical Technologies, Ltd. · 2004
- This deviceK050356 Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd. · 2005
- Descendant · cites it directly · 1 of its ownK062008 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 11 generations
- Root · 11 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 10 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 9 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
- 8 generations backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
- 7 generations backK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
- 6 generations backK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
- 5 generations backK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
- 4 generations backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- 3 generations backK033324 Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd. · 2004
- 2 generations backK041751 Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd. · 2004
- 1 generation backK043115 Laparoscopic Compression Anastomosis Clip (Lapcac)Niti Medical Technologies, Ltd. · 2004
- This deviceK050356 Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd. · 2005
Class I recalls in this family
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 |
|---|---|---|---|---|---|
| −11 | K933887 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1993 | — |
| −10 | K962043 | Auto Suture Modified VCS Clip Applier | United States Surgical, A Division of Tyco Healthc | 1996 | 7 |
| −9 | K994160 | Coalescent Surgical Sutured-Clip | Coalescent Surgical | 2000 | — |
| −8 | K012317 | Coalescent Surgical U-Clip | Coalescent Surgical | 2001 | — |
| −7 | K013664 | Coalescent Surgical U-Clip | Coalescent Surgical | 2002 | — |
| −6 | K021407 | Coalescent Surgical U-Clip - or Other TBD and Accessories | Coalescent Surgical | 2002 | — |
| −5 | K023125 | Coalescent U-Clip- and Accessories | Coalescent Surgical | 2002 | — |
| −4 | K024366 | Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 1 |
| −3 | K033324 | Compression Anastomosis Clip (Cac) | Niti Medical Technologies, Ltd. | 2004 | — |
| −2 | K041751 | Compression Anastomosis Clip (Cac) | Niti Medical Technologies, Ltd. | 2004 | — |
| −1 | K043115 | Laparoscopic Compression Anastomosis Clip (Lapcac) | Niti Medical Technologies, Ltd. | 2004 | — |
| 0 (this device) | K050356 | Compression Anastomosis Ring (Car) | Niti Medical Technologies, Ltd. | 2005 | — |
| +1 | 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 |
|---|---|---|
| 2006 | 1 | 0 |
| 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? (6)
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 |
|---|---|---|---|
| * | K033324 | Compression Anastomosis Clip (Cac)Summary page 2…the Division of General and Restorative Devices. Predicate Device: * Compression Anastomosis Clip (CAC) (NiTi Medical Technologies Ltd.) cleared under K033324, K041751 and K043115. • ProximateTM ILS Circular Stapler (Ethicon Endo-Surgery, Inc. USA) cleared under K920752 and… | 2004 |
| * | K041751 | Compression Anastomosis Clip (Cac)Summary page 2…ion of General and Restorative Devices. Predicate Device: * Compression Anastomosis Clip (CAC) (NiTi Medical Technologies Ltd.) cleared under K033324, K041751 and K043115. • ProximateTM ILS Circular Stapler (Ethicon Endo-Surgery, Inc. USA) cleared under K920752 and K983536.… | 2004 |
| * | K043115 | Laparoscopic Compression Anastomosis Clip (Lapcac)Summary page 2…eneral and Restorative Devices. Predicate Device: * Compression Anastomosis Clip (CAC) (NiTi Medical Technologies Ltd.) cleared under K033324, K041751 and K043115. • ProximateTM ILS Circular Stapler (Ethicon Endo-Surgery, Inc. USA) cleared under K920752 and K983536. · Prem… | 2004 |
| * | K920752 | Endopath Ils Endoscopic Circular StaplerSummary page 2…ical Technologies Ltd.) cleared under K033324, K041751 and K043115. • ProximateTM ILS Circular Stapler (Ethicon Endo-Surgery, Inc. USA) cleared under K920752 and K983536. · Premium Plus CEEA Circular Stapler (Auto Suture-United States Surgical, USA) cleared under K024275.… | 1992 |
| * | K983536 | Proximate Curved and Straight Intraluminal StaplersSummary page 2…ogies Ltd.) cleared under K033324, K041751 and K043115. • ProximateTM ILS Circular Stapler (Ethicon Endo-Surgery, Inc. USA) cleared under K920752 and K983536. · Premium Plus CEEA Circular Stapler (Auto Suture-United States Surgical, USA) cleared under K024275. Performance… | 1998 |
| * | K024275 | Auto Suture Premium Plus Ceea Disposable StaplerSummary page 2…do-Surgery, Inc. USA) cleared under K920752 and K983536. · Premium Plus CEEA Circular Stapler (Auto Suture-United States Surgical, USA) cleared under K024275. Performance Standards: No performance standards have been established for such device under Section 514 of the Fede… | 2003 |
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? (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 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 112 Class I recalls
- K940967Modified Endopath IlsEthicon Endo-Surgery, Inc. · 1994 · 2 generations back · ◆ in the 1994 ancestors bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 5 months on median.
- 7 of the 42 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K062008 (Niti Medical Technologies, Ltd., 2006) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K033324.
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/K050356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050356: 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/K050356
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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