510(k) · Cleared

Cleared

Influence Clip System

K981631510(k) TraditionalCleared Jul 28, 199882-day reviewClass II21 CFR 878.4300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cleared on Jul 28, 1998 as substantially equivalent to K954853 (United States Surgical, A Division of Tyco Healthc, 1995) and 2 other predicates after an 82-day review. Its family tree reaches back 1 generation to 1990.

Decided: Jul 28, 1998
Review: 82 days
Class: Class II
Product code: FZP
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K900926 (1990). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK900926 Trochanter Cable Grip System (Add'l Indications)Howmedica Corp. · 1990
This deviceK981631 Influence Clip SystemInfluence, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K900926	Trochanter Cable Grip System (Add'l Indications)	Howmedica Corp.	1990	—
0 (this device)	K981631	Influence Clip System	Influence, Inc.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1997	1	0

FIG. 1 — Lineage of K981631, 1990–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K954853	Auto Suture Suture Closure Summary page 1 …me: Influence Clip System Classification Name: Implantable Clip Product Code: 79FZP Predicate Devices: United States Surgical Corporation’s Auto Suture Suture Closure (K954853), Innovasive Devices, Inc.’s Y-Knot Suture Clip (K973313), and Howmedica, Inc.’s Dall-Miles Cable Grip System (K900926). - Indic…	United States Surgical, A Division of Tyco Healthc	1995	—
*	K973313	Innovasive Devices Y-Knot Suture Clip Summary page 1 …e Clip Product Code: 79FZP Predicate Devices: United States Surgical Corporation’s Auto Suture Suture Closure (K954853), Innovasive Devices, Inc.’s Y-Knot Suture Clip (K973313), and Howmedica, Inc.’s Dall-Miles Cable Grip System (K900926). - Indication for Use: The Influence Clip System is indicated fo…	Innovasive Devices, Inc.	1997	—
*	K900926	Trochanter Cable Grip System (Add'l Indications) Summary page 1 …Surgical Corporation’s Auto Suture Suture Closure (K954853), Innovasive Devices, Inc.’s Y-Knot Suture Clip (K973313), and Howmedica, Inc.’s Dall-Miles Cable Grip System (K900926). - Indication for Use: The Influence Clip System is indicated for permanent securing of two strands of surgical suture for sof…	Howmedica Corp.	1990	—

Also cleared against K954853: 2 other devices →

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?

None of the 3 ancestors has a recall.
2 other devices also cite its predicate K954853.

How does its category compare?

All FZP devices

FZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FZP

5in 2025

2007high 8 (2015) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FZP

90in 2025

2007high 227 (2022) · low 22 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FZP

1in 2020

2007high 6 (2008) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FZP

1,902in 2025

2007high 2,903 (2019) · low 981 (2008)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 Influence Clip System is intended for permanent securing of two strands of surgical suture for soft tissue approximation in open or laparoscopic surgical procedures.

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/K981631 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981631: Influence Clip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981631

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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