510(k) · Cleared
ClearedAntimicrobial Mediastinal Silicone Drain
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sil-Med Corp. · GBW Catheter, Peritoneal
Cleared on Aug 8, 1996 as substantially equivalent to K942709 (Sil-Med Corp., 1996) and 1 other predicate after a 134-day review. Its family tree reaches back 1 generation to 1990. 1 of the 3 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 8, 1996
- Review
- 134 days
- Class
- Class I
- Product code
- GBW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K900263 (1990). 2 ancestors in all. No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK900263 Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · Recalled (Class I)
- This deviceK961194 Antimicrobial Mediastinal Silicone DrainSil-Med Corp. · 1996
Class I recalls in this family
- K900263 Antimicrobial Multi-Lumen Central Venous Catheterdirect predicate · 1990
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900263 | Antimicrobial Multi-Lumen Central Venous Catheter | Arrow Intl., Inc. | 1990 | Class I |
| 0 (this device) | K961194 | Antimicrobial Mediastinal Silicone Drain | Sil-Med Corp. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
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.
1 device in this family has a Class I recall. 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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K942709 | Mediastinal Silicone DrainsSummary page 1…l; perforations (“eyes") on both flattened surfaces of tubing; external end has cutaway adapter; imprinted with drain size Predicate Device: Mediastinal Silicone Drain: K942709 Antimicrobial Multi-Luman Venous Catheter: K900263 Intended Use: Catheter for drainage of blood and fluid from mediastinum after… | 1996 |
| * | K900263 | Antimicrobial Multi-Lumen Central Venous CatheterSummary page 1…of tubing; external end has cutaway adapter; imprinted with drain size Predicate Device: Mediastinal Silicone Drain: K942709 Antimicrobial Multi-Luman Venous Catheter: K900263 Intended Use: Catheter for drainage of blood and fluid from mediastinum after chest surgery and/or trauma; for use with suction… | 1990 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K900263Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K942709.
How does its category compare?
All GBW devicesGBW 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
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GBW
28in 2023
MAUDE reports naming product code GBW, 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 | 0 | — | 1 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 1 | 0 |
| 2016 | 0 | — | 6 | 3 |
| 2017 | 0 | — | 0 | 21 |
| 2018 | 0 | — | 0 | 10 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 28 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
Catheter for drainage of blood and fluid from mediastinum after chest surgery and/or trauma; for use with suction apparatus
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/K961194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961194: Antimicrobial Mediastinal Silicone Drain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961194
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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