510(k) Report

510(k) · Cleared

Cleared

Schneider Wallstent (R)

K911292510(k) TraditionalCleared May 1, 199137-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

Pfizer Hospital Products Group, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on May 1, 1991 after a 37-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 57 later devices descend from it.

Decided
May 1, 1991
Review
37 days
Class
Class II
Product code
FGE
Recalls
None
Predicates
0

57 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 1998: 3 descendants cleared1997: 1 descendant cleared1996: 2 descendants cleared2001: 2 descendants cleared2009: 3 descendants cleared2011: 2 descendants cleared1999: 5 descendants cleared2006: 3 descendants cleared2013: 2 descendants cleared2003: 2 descendants cleared2008: 2 descendants cleared2012: 2 descendants cleared2002: 2 descendants cleared2000: 1 descendant cleared2015: 1 descendant cleared2010: 1 descendant cleared2022: 2 descendants cleared2025: 3 descendants cleared2023: 3 descendants cleared2014: 3 descendants cleared2021: 3 descendants cleared2019: 1 descendant cleared2024: 4 descendants cleared2020: 2 descendants cleared2018: 1 descendant cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK911292 Schneider Wallstent (R)Pfizer Hospital Products Group, Inc. · 1991
  2. Descendant · cites it directly · 55 of its ownK961262 Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic…Boston Scientific Scimed, Inc. · 1996
  3. Descendant · cites it directly · 54 of its ownK964119 Wallstent Transhepatic Biliary EndoprosthesisBoston Scientific Scimed, Inc. · 1997 · Recalled
  4. Descendant · 2 generations on · 40 of its ownK982184 Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998
  5. Descendant · 2 generations on · 37 of its ownK012752 Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · Recalled
  6. Descendant · 3 generations on · 23 of its ownK073667 Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008

Showing 5 of 57 descendants. See all descendants

Descendants cleared per year

1996: 21997: 11998: 31999: 52000: 12001: 22002: 22003: 22006: 32008: 22009: 32010: 12011: 22012: 22013: 22014: 32015: 12018: 12019: 12020: 22021: 32022: 22023: 32024: 42025: 32026: 1
1996high 5 (1999) · low 0 (2004)2026

Most influential descendants

Showing 5 of 57 · See all
  • K961262Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · cites it directly55descendants
  • K964119Wallstent Transhepatic Biliary EndoprosthesisBoston Scientific Scimed, Inc. · 1997 · cites it directly54descendants
  • K982184Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998 · 2 generations on40descendants
  • K012752Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · 2 generations on37descendants
  • K073667Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008 · 3 generations on23descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K911292Schneider Wallstent (R)Pfizer Hospital Products Group, Inc.1991—
+1K961262Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary…Boston Scientific Scimed, Inc.1996—
+1K964119Wallstent Transhepatic Biliary EndoprosthesisBoston Scientific Scimed, Inc.19976
+2K982184Wallstent EndoprosthesisBoston Scientific Scimed, Inc.1998—
+2K012752Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp20011
+3K073667Niti-S Biliary StentTaewoong Medical Co., Ltd.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199710
199830
199950
200010
200120
200220
200320
200630
200820
200930
201010
201120
201220
201320
201430
201510
201810
201910
202020
202130
202220
202330
202440
202530
202610
FIG. 1 — Lineage of K911292, 1991–2026Source: 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 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?

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

What descends from it? (57)

See all 57

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

NumberDeviceApplicantDecidedDescendants
K961262Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary EndoprosthesisBoston Scientific Scimed, Inc.199655
K964119Wallstent Transhepatic Biliary EndoprosthesisBoston Scientific Scimed, Inc.199754
K955728Cordis Biliary StentCordis Corp.19968
K980653Perflex Stainless Steel Stent and Delivery SystemCordis Corp.19987

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, K961262 (Boston Scientific Scimed, Inc., 1996) has gone furthest, with 55 descendants of its own.

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.

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—

More from Pfizer Hospital Products Group, Inc.

8 FDA decisions under this applicant name. See the company

  • K930156Mega Plus Super Lag ScrewPfizer Hospital Products Group, Inc. · 19941 recall
  • K915512Duracon Total Knee System Tibial ComponentsPfizer Hospital Products Group, Inc. · 19924 recalls
  • K920831Pca Total Hip System (Cementless Use)Pfizer Hospital Products Group, Inc. · 1992
  • K920034Duracon Modular Femoral Component and Femoral SpacPfizer Hospital Products Group, Inc. · 19922 recalls
  • K915184Howmedica Alumina Femoral HeadPfizer Hospital Products Group, Inc. · 1992

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https://510kreport.com/device/K911292 · printed Nov 4, 2026

Cite this page

510(k) Report. “K911292: Schneider Wallstent (R).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K911292

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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