510(k) · Cleared
ClearedSapphire Line Flat Drain/Kit with Spi-Argent II W/or W/Out Trocar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sil-Med Corp. · GBX Catheter, Irrigation
Cleared on Jun 26, 1996 as substantially equivalent to K942709 (Sil-Med Corp., 1996) and 1 other predicate after an 83-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Jun 26, 1996
- Review
- 83 days
- Class
- Class I
- Product code
- GBX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K926408 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK926408 Sil-Slip Flat Suction DrainSil-Med Corp. · 1994
- This deviceK961295 Sapphire Line Flat Drain/Kit with Spi-Argent II W/or W/Out TrocarSil-Med Corp. · 1996
- Descendant · cites it directly · 0 of its ownK063245 Elutia Coated Closed Surgical Wound DrainBacterin International, Inc. · 2007 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K063245Elutia Coated Closed Surgical Wound DrainBacterin International, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926408 | Sil-Slip Flat Suction Drain | Sil-Med Corp. | 1994 | — |
| 0 (this device) | K961295 | Sapphire Line Flat Drain/Kit with Spi-Argent II W/or W/Out Trocar | Sil-Med Corp. | 1996 | — |
| +1 | K063245 | Elutia Coated Closed Surgical Wound Drain | Bacterin International, Inc. | 2007 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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.
Planning a device in GBX? 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…et; offered with an introduction Trocar attached as an option; silver ion surface treated to ease | insertion and removal. Predicate Device: Mediastinal Silicone Drain: K942709 Sil-Slip Flat Suction Drain/Kit (with and without Trocar): K926408 Intended Use: For post-operative drainage of serosanguineous… | 1996 |
| * | K926408 | Sil-Slip Flat Suction DrainSummary page 1…er ion surface treated to ease | insertion and removal. Predicate Device: Mediastinal Silicone Drain: K942709 Sil-Slip Flat Suction Drain/Kit (with and without Trocar): K926408 Intended Use: For post-operative drainage of serosanguineous fluids and blood away from operative site; for use with suction re… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063245 | Elutia Coated Closed Surgical Wound Drain | 2007 | 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?
How does its category compare?
All GBX devicesGBX Catheter, Irrigation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GBX
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · GBX
Too few GBX 510(k)s in any year since 2007 to give a median.
Recalls per year · GBX
6in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GBX
1,179in 2025
MAUDE reports naming product code GBX, 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 | — | 0 | 11 |
| 2008 | 1 | — | 0 | 16 |
| 2009 | 0 | — | 0 | 24 |
| 2010 | 0 | — | 1 | 35 |
| 2011 | 0 | — | 0 | 41 |
| 2012 | 0 | — | 0 | 46 |
| 2013 | 0 | — | 0 | 49 |
| 2014 | 1 | — | 0 | 51 |
| 2015 | 0 | — | 0 | 58 |
| 2016 | 0 | — | 0 | 86 |
| 2017 | 0 | — | 1 | 176 |
| 2018 | 0 | — | 0 | 277 |
| 2019 | 0 | — | 0 | 196 |
| 2020 | 0 | — | 0 | 198 |
| 2021 | 0 | — | 1 | 383 |
| 2022 | 0 | — | 29 | 477 |
| 2023 | 0 | — | 0 | 628 |
| 2024 | 0 | — | 0 | 945 |
| 2025 | 0 | — | 6 | 1,179 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For post-operative drainage of serosanguineous fluids and blood away from operative site; for use with suction reservoir as a closed wound drain system
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/K961295 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961295: Sapphire Line Flat Drain/Kit with Spi-Argent II W/or W/Out Trocar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961295
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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