510(k) · Cleared
ClearedAuto Suture Endo Clip III5MM Clip Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Devices, A Division of Tyco Healthcare · FZP Clip, Implantable
Cleared on Feb 17, 2010 as substantially equivalent to K071406 (United States Surgical, A Division of Tyco Healthc, 2007) and 2 other predicates after a 21-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Feb 17, 2010
- Review
- 21 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K883018 (1988). No later device cites it as a predicate yet.
- Root · 3 generations backK883018 Auto Suture Disp. Endoscopic Surg. Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1988
- 2 generations backK061288 Auto Suture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2006
- 1 generation backK071406 Autosuture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2007
- This deviceK100242 Auto Suture Endo Clip III5MM Clip AdapterSurgical Devices, A Division of Tyco Healthcare · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K883018 | Auto Suture Disp. Endoscopic Surg. Clip Applier | United States Surgical, A Division of Tyco Healthc | 1988 | — |
| −2 | K061288 | Auto Suture Endo Clip Iii 5 MM Clip Applier | United States Surgical, A Division of Tyco Healthc | 2006 | — |
| −1 | K071406 | Autosuture Endo Clip Iii 5 MM Clip Applier | United States Surgical, A Division of Tyco Healthc | 2007 | — |
| 0 (this device) | K100242 | Auto Suture Endo Clip III5MM Clip Adapter | Surgical Devices, A Division of Tyco Healthcare | 2010 | — |
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? (3)
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 |
|---|---|---|---|
| * | K071406 | Autosuture Endo Clip Iii 5 MM Clip ApplierSummary page 1…CLASSIFICATION NAME: Implantable Clip PREDICATE DEVICE(S): Auto Suture Tm ENDO CLIP TM III 5mm Clip Applier (K071406, K061288) and Auto Suture' Tm ENDO CL IPTM Disposable Clip… | 2007 |
| * | K061288 | Auto Suture Endo Clip Iii 5 MM Clip ApplierSummary page 1…le Clip PREDICATE DEVICE(S): Auto Suture Tm ENDO CLIP TM III 5mm Clip Applier (K071406, K061288) and Auto Suture' Tm ENDO CL IPTM Disposable Clip Applier (K88301 6)… | 2006 |
| * | K883018 | Auto Suture Disp. Endoscopic Surg. Clip Applier Our reading of the summary gave K883016, FDA’s number for Polysafe Implant. Pacing Leads W/Tined Fixa. Tip (Cardiac Control Systems, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Auto Suture Disposable Clip Applier”. | 1988 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K071406.
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 Auto Suture ENDO CLIP III 5mm Clip Applier is primarily indicated for patients
undergoing laproscopic surgical procedures involving dissection and occlusion of blood
vessels, ducts and other tubular structures, and for radiographic marking.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100242 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100242: Auto Suture Endo Clip III5MM Clip Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100242
Report an extraction error
Are you the manufacturer?
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