510(k) · Cleared

Cleared

Mediastinal Silicone Drains

K942709510(k) TraditionalCleared Jan 4, 1996575-day reviewClass I21 CFR 878.4200

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

Sil-Med Corp. · GBW Catheter, Peritoneal

Cleared on Jan 4, 1996 after a 575-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.

Decided: Jan 4, 1996
Review: 575 days
Class: Class I
Product code: GBW
Recalls: None
Predicates: 0

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

This deviceK942709 Mediastinal Silicone DrainsSil-Med Corp. · 1996
Descendant · cites it directly · 3 of its ownK961392 Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent IISil-Med Corp. · 1997
Descendant · 2 generations on · 2 of its ownK012193 Amc Antimicrobial Pin/Wire SleeveSmith & Nephew, Inc. · 2002
Descendant · cites it directly · 1 of its ownK961295 Sapphire Line Flat Drain/Kit with Spi-Argent II W/or W/Out TrocarSil-Med Corp. · 1996
Descendant · 2 generations on · 0 of its ownK063245 Elutia Coated Closed Surgical Wound DrainBacterin International, Inc. · 2007 · Recalled
Descendant · 3 generations on · 0 of its ownK022688 Versabond AB Bone CementSmith & Nephew, Inc. · 2004 · Recalled

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

1996high 2 (1996) · low 0 (1998)2026

Most influential descendants

Showing 5 of 7 · See all

K961392Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent IISil-Med Corp. · 1997 · cites it directly3descendants
K012193Amc Antimicrobial Pin/Wire SleeveSmith & Nephew, Inc. · 2002 · 2 generations on2descendants
K961295Sapphire Line Flat Drain/Kit with Spi-Argent II W/or W/Out TrocarSil-Med Corp. · 1996 · cites it directly1descendant
K063245Elutia Coated Closed Surgical Wound DrainBacterin International, Inc. · 2007 · 2 generations on0descendants
K022688Versabond AB Bone CementSmith & Nephew, Inc. · 2004 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K942709	Mediastinal Silicone Drains	Sil-Med Corp.	1996	—
+1	K961392	Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent II	Sil-Med Corp.	1997	—
+2	K012193	Amc Antimicrobial Pin/Wire Sleeve	Smith & Nephew, Inc.	2002	—
+1	K961295	Sapphire Line Flat Drain/Kit with Spi-Argent II W/or W/Out Trocar	Sil-Med Corp.	1996	—
+2	K063245	Elutia Coated Closed Surgical Wound Drain	Bacterin International, Inc.	2007	2
+3	K022688	Versabond AB Bone Cement	Smith & Nephew, Inc.	2004	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
1997	1	0
2002	2	0
2004	1	0
2007	1	0

FIG. 1 — Lineage of K942709, 1996–2007Source: 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 GBW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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? (7)

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

Number	Device	Applicant	Decided	Descendants
K961392	Antimicrobial Peritoneal Dialysis Coil Catheter with Spi-Argent II	Sil-Med Corp.	1997	3
K961295	Sapphire Line Flat Drain/Kit with Spi-Argent II W/or W/Out Trocar	Sil-Med Corp.	1996	1
K961194	Antimicrobial Mediastinal Silicone Drain	Sil-Med Corp.	1996	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, K961392 (Sil-Med Corp., 1997) has gone furthest, with 3 descendants of its own.

How does its category compare?

All GBW devices

GBW Catheter, Peritoneal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GBW

FDA has decided no GBW device since 2007.

Median 510(k) review, days · GBW

Too few GBW 510(k)s in any year since 2007 to give a median.

Recalls per year · GBW

6in 2016

2007high 6 (2016) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GBW

28in 2023

2007high 28 (2023) · low 0 (2009)2025

MAUDE reports naming product code GBW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	1	1
2008	—	0	2
2009	—	1	0
2010	—	0	1
2011	—	0	1
2012	—	0	2
2013	—	0	2
2014	—	0	1
2015	—	1	0
2016	—	6	3
2017	—	0	21
2018	—	0	10
2019	—	0	1
2020	—	0	3
2021	—	0	8
2022	—	0	6
2023	—	0	28
2024	—	0	0
2025	—	0	0
2026	—	1 (1)	—

https://510kreport.com/device/K942709 · printed Nov 5, 2026

Cite this page

510(k) Report. “K942709: Mediastinal Silicone Drains.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K942709

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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