510(k) · Cleared
ClearedCompression Anastomosis Clip (Cac)
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 10, 2004 as substantially equivalent to K931056 (American Cyanamid Co., 1993) and 2 other predicates after a 208-day review. Its family tree reaches back 8 generations to 1993. 7 later devices descend from it.
- Decided
- May 10, 2004
- Review
- 208 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K933887 (1993). 32 ancestors in all, the oldest K771412 (1977). 7 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK933887 Implantable ClipUnited States Surgical, A Division of Tyco Healthc · 1993
- 7 generations backK962043 Auto Suture Modified VCS Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1996 · Recalled
- 6 generations backK994160 Coalescent Surgical Sutured-ClipCoalescent Surgical · 2000
- 5 generations backK012317 Coalescent Surgical U-ClipCoalescent Surgical · 2001
- 4 generations backK013664 Coalescent Surgical U-ClipCoalescent Surgical · 2002
- 3 generations backK021407 Coalescent Surgical U-Clip - or Other TBD and AccessoriesCoalescent Surgical · 2002
- 2 generations backK023125 Coalescent U-Clip- and AccessoriesCoalescent Surgical · 2002
- 1 generation backK024366 Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical · 2003 · Recalled
- This deviceK033324 Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd. · 2004
- Descendant · cites it directly · 6 of its ownK041751 Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd. · 2004
- Descendant · cites it directly · 5 of its ownK043115 Laparoscopic Compression Anastomosis Clip (Lapcac)Niti Medical Technologies, Ltd. · 2004
- Descendant · cites it directly · 2 of its ownK050356 Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd. · 2005
- Descendant · 2 generations on · 1 of its ownK250541 Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK062008 Endo Car Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd. · 2006
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K041751Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd. · 2004 · cites it directly6descendants
- K043115Laparoscopic Compression Anastomosis Clip (Lapcac)Niti Medical Technologies, Ltd. · 2004 · cites it directly5descendants
- K050356Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd. · 2005 · cites it directly2descendants
- K250541Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc. · 2025 · 2 generations on1descendant
- K062008Endo Car Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd. · 2006 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K933887 | Implantable Clip | United States Surgical, A Division of Tyco Healthc | 1993 | — |
| −7 | K962043 | Auto Suture Modified VCS Clip Applier | United States Surgical, A Division of Tyco Healthc | 1996 | 7 |
| −6 | K994160 | Coalescent Surgical Sutured-Clip | Coalescent Surgical | 2000 | — |
| −5 | K012317 | Coalescent Surgical U-Clip | Coalescent Surgical | 2001 | — |
| −4 | K013664 | Coalescent Surgical U-Clip | Coalescent Surgical | 2002 | — |
| −3 | K021407 | Coalescent Surgical U-Clip - or Other TBD and Accessories | Coalescent Surgical | 2002 | — |
| −2 | K023125 | Coalescent U-Clip- and Accessories | Coalescent Surgical | 2002 | — |
| −1 | K024366 | Coalescent Surgical U-Clip and Accessories | Coalescent Surgical | 2003 | 1 |
| 0 (this device) | K033324 | Compression Anastomosis Clip (Cac) | Niti Medical Technologies, Ltd. | 2004 | — |
| +1 | K041751 | Compression Anastomosis Clip (Cac) | Niti Medical Technologies, Ltd. | 2004 | — |
| +1 | K043115 | Laparoscopic Compression Anastomosis Clip (Lapcac) | Niti Medical Technologies, Ltd. | 2004 | — |
| +1 | K050356 | Compression Anastomosis Ring (Car) | Niti Medical Technologies, Ltd. | 2005 | — |
| +2 | K250541 | Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows, Inc. | 2025 | — |
| +2 | K062008 | Endo Car Compression Anastomosis Ring (Car) | Niti Medical Technologies, Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 FZP? 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? (4)
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 |
|---|---|---|---|
| * | K931056 | Davis+Geck Valtrac Biofrag Anastomosis RingSummary page 2…ed by the Division of General and Restorative Devices. Predicate Device: Valtrac Biofregmentable Anastomosis Ring (Devis + Geck) cleared under K931056 ProximateTM Linear Cutter and Stapler (Ethicon Endo-Surgery, Inc. USA) cleared under K020779. U-Cl… | 1993 |
| * | K020779 | Proximate and Endopath Linear Cutters and StaplersSummary page 2…stomosis Ring (Devis + Geck) cleared under K931056 ProximateTM Linear Cutter and Stapler (Ethicon Endo-Surgery, Inc. USA) cleared under K020779. U-Clip TM , (Coalescent Surgical, Inc. USA) cleared under K024366. Murphy's Button, preamendments device. Perfo… | 2002 |
| * | K024366 | Coalescent Surgical U-Clip and AccessoriesSummary page 2…mateTM Linear Cutter and Stapler (Ethicon Endo-Surgery, Inc. USA) cleared under K020779. U-Clip TM , (Coalescent Surgical, Inc. USA) cleared under K024366. Murphy's Button, preamendments device. Performance Standards: No performance standards have been establish… | 2003 |
| * | — | Murphy's Button Named without a submission number |
What descends from it? (7)
3 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 11 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 32 ancestors have a recall of any class.
- Of its descendants, K041751 (Niti Medical Technologies, Ltd., 2004) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K931056.
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 CAC (Compression Anastomosis Clip) is intended to be used to facilitate colonic side-to-side anastomosis yielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient to maintain the anastomosis, the NiTI CAC is passed from the body. The NiTI CAC is not applicable through trocars in laparoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033324: Compression Anastomosis Clip (Cac).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033324
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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