510(k) · Cleared
ClearedPremium Surgiclip III
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · FZP Clip, Implantable
Cleared on Oct 30, 2014 as substantially equivalent to K853650 (United States Surgical, A Division of Tyco Healthc, 1985) after a 29-day review. Its family tree reaches back 1 generation to 1985. 2 later devices descend from it.
- Decided
- Oct 30, 2014
- Review
- 29 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K853650 (1985). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK853650 Auto Suture Titanium Hemostatic ClipUnited States Surgical, A Division of Tyco Healthc · 1985
- This deviceK142869 Premium Surgiclip IIICovidien · 2014
- Descendant · cites it directly · 1 of its ownK143644 Premium Surgiclip¿; Endo Clip¿; AcuClip¿Covidien · 2015
- Descendant · 2 generations on · 0 of its ownK221495 SOLID CLIP™ Single Use Clip ApplierMedscope Biotech Co., Ltd. · 2024
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 |
|---|---|---|---|---|---|
| −1 | K853650 | Auto Suture Titanium Hemostatic Clip | United States Surgical, A Division of Tyco Healthc | 1985 | — |
| 0 (this device) | K142869 | Premium Surgiclip III | Covidien | 2014 | — |
| +1 | K143644 | Premium Surgiclip¿; Endo Clip¿; AcuClip¿ | Covidien | 2015 | — |
| +2 | K221495 | SOLID CLIP™ Single Use Clip Applier | Medscope Biotech Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K853650 | Auto Suture Titanium Hemostatic ClipSummary page 4…clip is a Class II device PREDICATE DEVICE(S): Premium Surgiclip™ Small 9.0” Clip Applier [K853650] (formerly AutoSuture™ Hemostatic Clips) DEVICE DESCRIPTION: The Pre… | 1985 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143644 | Premium Surgiclip¿; Endo Clip¿; AcuClip¿ | 2015 | 1 |
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?
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Premium Surgiclip™ III clip applier has application in many types of surgical procedures to occlude vessels and other tubular structures and for vagotomy, sympathectomy, and radiographic markings.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142869 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142869: Premium Surgiclip III.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142869
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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