510(k) · Cleared

Recalled · 2011

TI-Cron and Dacron Sutures

K930591510(k) TraditionalCleared Dec 17, 1993316-day reviewClass II21 CFR 878.5000Recalls 6

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

Davis & Geck, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Dec 17, 1993 after a 316-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 21 later devices descend from it. It has been recalled 6 times.

Decided: Dec 17, 1993
Review: 316 days
Class: Class II
Product code: GAT
Recalls: 6
Predicates: 0

21 later devices descend from it, 5 citing it directly.

This deviceK930591 TI-Cron and Dacron SuturesDavis & Geck, Inc. · 1993
Descendant · cites it directly · 15 of its ownK081050 Parietex Progrip MeshSofradim Production · 2008
Descendant · 2 generations on · 6 of its ownK103682 Parietex ProgripSofradim Production · 2011
Descendant · 2 generations on · 6 of its ownK101519 Parietex Plug and PatchSofradim Production · 2010
Descendant · 2 generations on · 6 of its ownK101197 Parie Tene Progrip MeshSofradim Production · 2010
Descendant · 3 generations on · 5 of its ownK142900 Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester…Sofradim Production · 2014

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2000high 3 (2014) · low 0 (2001)2026

Most influential descendants

Showing 5 of 21 · See all

K081050Parietex Progrip MeshSofradim Production · 2008 · cites it directly15descendants
K103682Parietex ProgripSofradim Production · 2011 · 2 generations on6descendants
K101519Parietex Plug and PatchSofradim Production · 2010 · 2 generations on6descendants
K101197Parie Tene Progrip MeshSofradim Production · 2010 · 2 generations on6descendants
K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug…Sofradim Production · 2014 · 3 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K930591	TI-Cron and Dacron Sutures	Davis & Geck, Inc.	1993	—
+1	K081050	Parietex Progrip Mesh	Sofradim Production	2008	—
+2	K103682	Parietex Progrip	Sofradim Production	2011	—
+2	K101519	Parietex Plug and Patch	Sofradim Production	2010	—
+2	K101197	Parie Tene Progrip Mesh	Sofradim Production	2010	—
+3	K142900	Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh)…	Sofradim Production	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2006	1	0
2008	2	0
2010	2	0
2011	1	0
2014	3	0
2015	1	0
2021	1	0
2022	3	0
2023	1	0
2024	1	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K930591, 1993–2026Source: 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 GAT? 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 GAT device

#1 K230311 HyperSuturescore 20.2 · 7 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K081050	Parietex Progrip Mesh	Sofradim Production	2008	15
K211792	StitchKit	Origami Surgical Inc .	2021	1
K082535	Covidien Sports Surgery as Meniscal Repair Device	Surgical Devices, A Global Business Unit Covidien	2008	0
K060163	Cardioflon, Cardioxyl	Peters Surgical	2006	0
K994000	Polyester	Trading Consultants and Distributors Intl., Inc.	2000	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 3, 2011	Not classified	Z-2825-2011	Equipment maintenance	Potential for the sterile barrier to be breached compromising the sterility of the product
Jun 3, 2011	Not classified	Z-2827-2011	Equipment maintenance	Potential for the sterile barrier to be breached compromising the sterility of the product
Jun 3, 2011	Not classified	Z-2830-2011	Equipment maintenance	Potential for the sterile barrier to be breached compromising the sterility of the product
Jun 3, 2011	Not classified	Z-2826-2011	Equipment maintenance	Potential for the sterile barrier to be breached compromising the sterility of the product
Jun 3, 2011	Not classified	Z-2829-2011	Equipment maintenance	Potential for the sterile barrier to be breached compromising the sterility of the product
Jun 3, 2011	Not classified	Z-2828-2011	Equipment maintenance	Potential for the sterile barrier to be breached compromising the sterility of the product

The 5 latest of 6 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K081050 (Sofradim Production, 2008) has gone furthest, with 15 descendants of its own.

How does its category compare?

All GAT devices

GAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAT

5in 2025

2007high 11 (2010) · low 1 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAT

30in 2025

2007high 220 (2023) · low 27 (2010)2026

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

Recalls per year · GAT

1in 2011

2007high 3 (2010) · low 0 (2008)2026

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

Adverse event reports per year · GAT

2,956in 2025

2007high 2,956 (2025) · low 15 (2007)2025

MAUDE reports naming product code GAT, 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	40	1	15
2008	4	93	0	15
2009	9	57	0	55
2010	11	27	3	79
2011	1	—	1	97
2012	6	61	0	253
2013	4	123	0	210
2014	4	45	0	165
2015	7	125	0	626
2016	10	139	0	688
2017	6	57	0	1,104
2018	6	95	0	1,453
2019	4	79	0	1,251
2020	5	201	0	1,220
2021	4	92	0	1,643
2022	5	109	0	1,419
2023	8	220	0	2,038
2024	3	140	0	2,597
2025	5	30	0	2,956
2026	5	83	0	—

https://510kreport.com/device/K930591 · printed Nov 3, 2026

Cite this page

510(k) Report. “K930591: TI-Cron and Dacron Sutures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K930591

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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