510(k) · Cleared
ClearedAuto Suture Titanium Hemostatic Clip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Surgical, A Division of Tyco Healthc · FZP Clip, Implantable
Cleared on Sep 19, 1985 after a 16-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Sep 19, 1985
- Review
- 16 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 4 citing it directly.
- This deviceK853650 Auto Suture Titanium Hemostatic ClipUnited States Surgical, A Division of Tyco Healthc · 1985
- Descendant · cites it directly · 4 of its ownK972745 Titanium Hemostatic ClipEisner USA, Inc. · 1997
- Descendant · cites it directly · 3 of its ownK981645 Titanium Hemostatic ClipVitalitec Int'L., Inc. · 1998
- Descendant · cites it directly · 2 of its ownK142869 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 ownK242541 Gem ZipclipSynovis Micro Companies Alliance A Subsidiary of Baxter Int · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K972745Titanium Hemostatic ClipEisner USA, Inc. · 1997 · cites it directly4descendants
- K981645Titanium Hemostatic ClipVitalitec Int'L., Inc. · 1998 · cites it directly3descendants
- K142869Premium Surgiclip IIICovidien · 2014 · cites it directly2descendants
- K143644Premium Surgiclip¿; Endo Clip¿; AcuClip¿Covidien · 2015 · cites it directly1descendant
- K242541Gem ZipclipSynovis Micro Companies Alliance A Subsidiary of Baxter Int · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K853650 | Auto Suture Titanium Hemostatic Clip | United States Surgical, A Division of Tyco Healthc | 1985 | — |
| +1 | K972745 | Titanium Hemostatic Clip | Eisner USA, Inc. | 1997 | — |
| +1 | K981645 | Titanium Hemostatic Clip | Vitalitec Int'L., Inc. | 1998 | — |
| +1 | K142869 | Premium Surgiclip III | Covidien | 2014 | — |
| +1 | K143644 | Premium Surgiclip¿; Endo Clip¿; AcuClip¿ | Covidien | 2015 | — |
| +2 | K242541 | Gem Zipclip | Synovis Micro Companies Alliance A Subsidiary of Baxter Int | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
4 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?
- Of its descendants, K972745 (Eisner USA, Inc., 1997) has gone furthest, with 4 descendants of its own.
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 | — |
https://510kreport.com/device/K853650 · printed Nov 4, 2026
Cite this page
510(k) Report. “K853650: Auto Suture Titanium Hemostatic Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K853650
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026