510(k) · Cleared

Cleared

Ivs Tunneller

K010035510(k) TraditionalCleared Apr 4, 200190-day reviewClass II21 CFR 878.3300

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

United States Surgical, A Division of Tyco Healthc · FTL Mesh, Surgical, Polymeric

Cleared on Apr 4, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 86 later devices descend from it.

Decided: Apr 4, 2001
Review: 90 days
Class: Class II
Product code: FTL
Recalls: None
Predicates: 0

86 later devices descend from it, 3 citing it directly.

This deviceK010035 Ivs TunnellerUnited States Surgical, A Division of Tyco Healthc · 2001
Descendant · cites it directly · 70 of its ownK040537 Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc. · 2004
Descendant · 2 generations on · 30 of its ownK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
Descendant · 2 generations on · 20 of its ownK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
Descendant · 2 generations on · 17 of its ownK051485 Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005
Descendant · 3 generations on · 13 of its ownK092207 Restorelle Polypropylene MeshMpathy Medical Devices, Inc. · 2009

Showing 5 of 86 descendants. See all descendants

Descendants cleared per year

2004high 12 (2008) · low 0 (2019)2026

Most influential descendants

Showing 5 of 86 · See all

K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc. · 2004 · cites it directly70descendants
K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · 2 generations on30descendants
K071512Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008 · 2 generations on20descendants
K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005 · 2 generations on17descendants
K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc. · 2009 · 3 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010035	Ivs Tunneller	United States Surgical, A Division of Tyco Healthc	2001	—
+1	K040537	Ams Apogee Vault Suspension System	American Medical Systems, Inc.	2004	—
+2	K050445	Ams Collagen Dermal Matrix	American Medical Systems, Inc.	2005	1
+2	K071512	Gynecare Prolift +M* Pelvic Floor Repair Systems	ETHICON, Inc.	2008	—
+2	K051485	Ams Pelvic Floor Repair System	American Medical Systems, Inc.	2005	—
+3	K092207	Restorelle Polypropylene Mesh	Mpathy Medical Devices, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	2	0
2006	4	0
2007	3	0
2008	12	0
2009	8	0
2010	5	0
2011	9	0
2012	11	0
2013	7	0
2014	2	0
2015	2	0
2016	2	0
2017	1	0
2018	3	0
2021	1	0
2022	2	0
2023	3	0
2024	2	0
2025	3	0
2026	3	0

FIG. 1 — Lineage of K010035, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 FTL? 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 FTL device

#1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) 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? (86)

See all 86

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K040537	Ams Apogee Vault Suspension System	American Medical Systems, Inc.	2004	70
K050516	T-Sling	Herniamesh S.R.L.	2006	13
K073164	Ivs Tunneller Devices	Covidien UK Manufacturing, Ltd.	2008	0

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, K040537 (American Medical Systems, Inc., 2004) has gone furthest, with 70 descendants of its own.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FTL

6in 2025

2007high 23 (2008) · low 2 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTL

30in 2025

2007high 213 (2012) · low 29 (2023)2026

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

Recalls per year · FTL

1in 2020

2007high 12 (2010) · low 0 (2015)2026

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

Adverse event reports per year · FTL

3,487in 2025

2007high 26,519 (2013) · low 1,569 (2008)2025

MAUDE reports naming product code FTL, 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	20	92	2	1,737
2008	23	114	1	1,569
2009	15	97	1	1,906
2010	18	132	12	2,175
2011	15	90	8	3,608
2012	12	213	2	14,700
2013	8	90	1	26,519
2014	11	70	3	2,683
2015	12	121	0	2,526
2016	3	186	0	2,417
2017	6	132	1	3,947
2018	12	105	1	11,893
2019	4	99	0	21,724
2020	5	138	1	18,819
2021	2	—	0	16,284
2022	6	195	0	11,439
2023	4	29	0	8,025
2024	2	—	0	8,565
2025	6	30	0	3,487
2026	2	—	0	—

https://510kreport.com/device/K010035 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010035: Ivs Tunneller.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010035

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026