510(k) Report

510(k) · Decided

Decided

Scuba Biliary Stent System

K092352510(k) TraditionalDecided Mar 16, 2010224-day reviewClass II21 CFR 876.5010

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

Invatec S.P.A. · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Mar 16, 2010 as substantially equivalent to K012590 (Cordis Corp., 2001) and 2 other predicates after a 224-day review. Its family tree reaches back 8 generations to 1991.

Decided
Mar 16, 2010
Review
224 days
Class
Class II
Product code
FGE
Recalls
None
Predicates
3

Its longest line of descent runs back 8 generations to K905720 (1991). 23 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 2 other ancestors2001: 2 other ancestors1998: 2 other ancestors1997: 2 other ancestors2000: 3 other ancestors1999: 3 other ancestors1991: 1 other ancestorK905720 · Palmaz Biliary Stent · Johnson & Johnson Interventional Systems · 1991K990631 · Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC · Cordis Corp. · 1999×2: 2 generations cleared close together, K991028 (1999), K992755 (1999) K994156 · Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary Stent, Models PQ294B, PQ394B · Cordis Corp. · 2000×2: 2 generations cleared close together, K012056 (2001), K012590 (2001) K033394 · Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035 Delivery System · Cordis Corp. · 2003 · recalled19901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 4 other ancestors3 generations back: 6 other ancestors4 generations back: 3 other ancestors5 generations back: 1 other ancestor K033394 · Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035 Delivery System · Cordis Corp. · 2003 · recalledK012590 · Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery System · Cordis Corp. · 2001K012056 · Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery System · Cordis Europa, N.V. · 2001K994156 · Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary Stent, Models PQ294B, PQ394B · Cordis Corp. · 2000K992755 · Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Cordis Crimping Tools, Cordis Introducer Tube · Cordis, A Johnson & Johnson Co. · 1999K991028 · Cordis Palmaz Corinthian Transhepatic Biliary Stent and Accessories · Cordis Corp. · 1999K990631 · Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC · Cordis Corp. · 1999K905720 · Palmaz Biliary Stent · Johnson & Johnson Interventional Systems · 1991−50
  1. Root · 8 generations backK905720 Palmaz Biliary StentJohnson & Johnson Interventional Systems · 1991
  2. 7 generations backK990631 Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis Corp. · 1999
  3. 6 generations backK991028 Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp. · 1999
  4. 5 generations backK992755 Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis, A Johnson & Johnson Co. · 1999
  5. 4 generations backK994156 Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary…Cordis Corp. · 2000
  6. 3 generations backK012056 Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018…Cordis Europa, N.V. · 2001
  7. 2 generations backK012590 Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035…Cordis Corp. · 2001
  8. 1 generation backK033394 Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035…Cordis Corp. · 2003 · Recalled
  9. This deviceK092352 Scuba Biliary Stent SystemInvatec S.P.A. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K905720Palmaz Biliary StentJohnson & Johnson Interventional Systems1991—
−7K990631Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model…Cordis Corp.1999—
−6K991028Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp.1999—
−5K992755Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System…Cordis, A Johnson & Johnson Co.1999—
−4K994156Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary Stent, Models…Cordis Corp.2000—
−3K012056Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery SystemCordis Europa, N.V.2001—
−2K012590Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery…Cordis Corp.2001—
−1K033394Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035 Delivery…Cordis Corp.20031
0 (this device)K092352Scuba Biliary Stent SystemInvatec S.P.A.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199720
199820
199930
200030
200120
200320
FIG. 1 — Lineage of K092352, 1991–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 FGE? 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 FGE device

  1. #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K012590Cordis Palmaz Genesis Transhepatic Biliary Stent on Opta Pro .035 Delivery System
Summary page 1
…0 10, Product Code FUE) Classification: II Predicate Devices * Cordis PALMAZ® GENESISTm Transhepatic Biliary Stent on OPTATM PRO .035" Delivery System (K012590, K033394) • Medtronic RACER Biliary Stent System (K032768) Device Description The SCUBA Biliary Stent System consists of a ba…
Cordis Corp.2001—
*K033394Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035 Delivery System
Summary page 1
…duct Code FUE) Classification: II Predicate Devices * Cordis PALMAZ® GENESISTm Transhepatic Biliary Stent on OPTATM PRO .035" Delivery System (K012590, K033394) • Medtronic RACER Biliary Stent System (K032768) Device Description The SCUBA Biliary Stent System consists of a balloon-exp…
Cordis Corp.20031
*K032768Medtronic, Inc. Racer Biliary Stent System (Racer), Model XD#YF (L)
Summary page 1
…vices * Cordis PALMAZ® GENESISTm Transhepatic Biliary Stent on OPTATM PRO .035" Delivery System (K012590, K033394) • Medtronic RACER Biliary Stent System (K032768) Device Description The SCUBA Biliary Stent System consists of a balloon-expandable MP35N (cobalt, nickel, chromium molybdenum a…
Medtronic Ave, Inc.20031

Also cleared against K012590: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
  • 2 of the 23 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K012590.

How does its category compare?

All FGE devices

FGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · FGE

7in 2025

2007: 42008: 112009: 72010: 92011: 92012: 82013: 52014: 82015: 82016: 42017: 92018: 72019: 22020: 42021: 12022: 62023: 62024: 62025: 72026 (partial year): 8
2007high 11 (2008) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FGE

257in 2025

2007: 316 days median2008: 214 days median2009: 160 days median2010: 81 days median2011: 114 days median2012: 96 days median2013: 161 days median2014: 156 days median2015: 79 days median2016: 49 days median2017: 59 days median2018: 215 days median2020: 121 days median2022: 101 days median2023: 199 days median2024: 188 days median2025: 257 days median2026 (partial year): 153 days median
2007high 316 (2007) · low 49 (2016)2026

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

Recalls per year · FGE

1in 2024

2007: 542008: 932009: 182010: 322011: 22012: 42013: 32017: 12018: 432019: 132020: 12021: 272022: 212023: 192024: 12026 (partial year): 11
2007high 93 (2008) · low 0 (2014)2026

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

Adverse event reports per year · FGE

1,923in 2025

2007: 1,0062008: 1,4652009: 1,6552010: 1,4342011: 1,3212012: 1,1832013: 1,0602014: 1,2702015: 1,5432016: 1,4532017: 1,5152018: 1,6812019: 1,8962020: 2,1822021: 2,2972022: 1,7492023: 1,6152024: 1,9482025: 1,923
2007high 2,297 (2021) · low 1,006 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074316541,006
200811214931,465
20097160181,655
2010981321,434
2011911421,321
201289641,183
2013516131,060
2014815601,270
201587901,543
201644901,453
201795911,515
20187215431,681
20192—131,896
2020412112,182
20211—272,297
20226101211,749
20236199191,615
2024618811,948
2025725701,923
2026815311—

What is it indicated for?

SCUBA Biliary Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.

Indications for use as stated in the FDA summary.

Also cleared against K012590

3 other devices cite the same predicate.

  • K033909Wavemax Balloon-Expandable Transhepatic Biliary Stent SystemAbbott Laboratories · 2004
  • K033394Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035 Delivery SystemCordis Corp. · 20031 recall
  • K020809Modification to Cordis Palmaz Genesis Transhepatic Biliary StentCordis Corp. · 2002

More from Invatec S.P.A.

4 FDA decisions under this applicant name. See the company

  • K100921Admiral Xtreme Pta Balloon Dilatation CatheterInvatec S.P.A. · 2010
  • K092361Reef HP 0.035 Otw Pta Balloon Dilatation CatheterInvatec S.P.A. · 2009
  • K092177MO.MA Ultra Proximal Cerebral Protection Device, Model MUS0130069X6Invatec S.P.A. · 20093 recalls

Recent decisions in FGE

The FGE category page

  • K254179Drainage CatheterCanyon Medical, Inc. · 2026
  • K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc. · 2026
  • K260835ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · 2026
  • K253393Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019…Hangzhou AGS MedTech Co., Ltd. · 2026
  • K253832Dilation Balloon CatheterMirco-Tech (Nanjing) Co., Ltd. · 2026

https://510kreport.com/device/K092352 · printed Nov 5, 2026

Cite this page

510(k) Report. “K092352: Scuba Biliary Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092352

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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