510(k) Report

510(k) · Cleared

Cleared

Palmaz Biliary Stent

K905720510(k) TraditionalCleared Feb 5, 199146-day reviewClass II21 CFR 870.1250

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

Johnson & Johnson Interventional Systems · DQY Catheter, Percutaneous

Cleared on Feb 5, 1991 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 34 later devices descend from it.

Decided
Feb 5, 1991
Review
46 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
0

34 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 1999: 9 descendants cleared1998: 2 descendants cleared2002: 3 descendants cleared1996: 1 descendant cleared2000: 2 descendants cleared2001: 4 descendants cleared2003: 4 descendants cleared2010: 1 descendant cleared2004: 3 descendants cleared2006: 3 descendants cleared2014: 1 descendant cleared2007: 1 descendant cleared1990200020102020
  1. This deviceK905720 Palmaz Biliary StentJohnson & Johnson Interventional Systems · 1991
  2. Descendant · cites it directly · 21 of its ownK990631 Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis Corp. · 1999
  3. Descendant · cites it directly · 19 of its ownK991028 Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp. · 1999
  4. Descendant · 2 generations on · 17 of its ownK992755 Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery…Cordis, A Johnson & Johnson Co. · 1999
  5. Descendant · 3 generations on · 11 of its ownK994156 Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary…Cordis Corp. · 2000
  6. Descendant · 3 generations on · 9 of its ownK012056 Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018…Cordis Europa, N.V. · 2001

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

1996: 11998: 21999: 92000: 22001: 42002: 32003: 42004: 32006: 32007: 12010: 12014: 1
1996high 9 (1999) · low 0 (1997)2026

Most influential descendants

Showing 5 of 34 · See all
  • K990631Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model PC125BPS…Cordis Corp. · 1999 · cites it directly21descendants
  • K991028Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp. · 1999 · cites it directly19descendants
  • K992755Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Cordis Crimping…Cordis, A Johnson & Johnson Co. · 1999 · 2 generations on17descendants
  • K994156Modification to Cordis Palmaz Corinthian IQ Transhepatic Biliary Stent, Models PQ294B…Cordis Corp. · 2000 · 3 generations on11descendants
  • K012056Cordis Palmaz Genesis Transhepatic Biliary Stent on Slalom .018 Delivery SystemCordis Europa, N.V. · 2001 · 3 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K905720Palmaz Biliary StentJohnson & Johnson Interventional Systems1991—
+1K990631Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model…Cordis Corp.1999—
+1K991028Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp.1999—
+2K992755Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System…Cordis, A Johnson & Johnson Co.1999—
+3K994156Modification 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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199820
199990
200020
200140
200230
200340
200430
200630
200710
201010
201410
FIG. 1 — Lineage of K905720, 1991–2014Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DQY? 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 DQY device

  1. #1 K234115 APRO 55 Catheterscore 17.5 · 6 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (34)

See all 34

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

NumberDeviceApplicantDecidedDescendants
K990631Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model PC125BPS…Cordis Corp.199921
K991028Cordis Palmaz Corinthian Transhepatic Biliary Stent and AccessoriesCordis Corp.199919
K955728Cordis Biliary StentCordis Corp.19968
K980653Perflex Stainless Steel Stent and Delivery SystemCordis Corp.19987
K983075Guidant Megalink Biliary Stent, Model #'S 1002949-18, 1002949-28, 1002949-38Guidant Corp.19994
K980290Iti StentIntratherapeutics, Inc.19984
K991929IntrastentIntratherapeutics, Inc.19993
K993904Intrastent Doublestrut LDIntratherapeutics, Inc.20001
K020809Modification to Cordis Palmaz Genesis Transhepatic Biliary StentCordis Corp.20020
K992816Modification to IntrastentIntratherapeutics, Inc.19990

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, K990631 (Cordis Corp., 1999) has gone furthest, with 21 descendants of its own.

How does its category compare?

All DQY devices

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

FDA decisions per year · DQY

21in 2025

2007: 162008: 312009: 372010: 222011: 362012: 302013: 322014: 192015: 272016: 222017: 262018: 252019: 302020: 202021: 182022: 182023: 182024: 162025: 212026 (partial year): 11
2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007: 85 days median2008: 66 days median2009: 73 days median2010: 74 days median2011: 71 days median2012: 87 days median2013: 92 days median2014: 127 days median2015: 118 days median2016: 117 days median2017: 113 days median2018: 106 days median2019: 111 days median2020: 120 days median2021: 81 days median2022: 74 days median2023: 114 days median2024: 87 days median2025: 115 days median2026 (partial year): 30 days median
2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007: 62008: 122009: 172010: 322011: 62012: 22013: 36, 1 Class I2014: 32015: 32016: 22, 7 Class I2017: 82018: 22019: 12020: 22021: 22023: 172024: 12025: 1, 1 Class I2026 (partial year): 2, 1 Class I
2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007: 3132008: 4962009: 8192010: 1,2932011: 1,2112012: 1,1912013: 1,3522014: 1,4972015: 2,3372016: 2,2522017: 2,4892018: 2,8552019: 2,9022020: 2,8892021: 3,0062022: 2,6432023: 3,0492024: 3,1902025: 3,056
2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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
200716856313
2008316612496
2009377317819
20102274321,293
2011367161,211
2012308721,191
2013329236 (1)1,352
20141912731,497
20152711832,337
20162211722 (7)2,252
20172611382,489
20182510622,855
20193011112,902
20202012022,889
2021188123,006
2022187402,643
202318114173,049
2024168713,190
2025211151 (1)3,056
202611302 (1)—

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2 FDA decisions under this applicant name. See the company

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https://510kreport.com/device/K905720 · printed Nov 6, 2026

Cite this page

510(k) Report. “K905720: Palmaz Biliary Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905720

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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