510(k) Report

510(k) · Cleared

Cleared

Disposable Bending Cannula PR-233Q

K011149510(k) SpecialCleared May 15, 200129-day reviewClass II21 CFR 876.1500

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

The Olympus Optical Co. · ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula

Cleared on May 15, 2001 as substantially equivalent to K950729 (Olympus America, Inc., 1995) and 1 other predicate after a 29-day review. Its family tree reaches back 1 generation to 1995. 12 later devices descend from it.

Decided
May 15, 2001
Review
29 days
Class
Class II
Product code
ODD
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K950166 (1995). 2 ancestors in all. 12 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor2005: 1 descendant cleared2009: 1 descendant cleared2015: 1 descendant cleared2025: 1 descendant cleared2018: 1 descendant cleared2023: 1 descendant cleared2026: 3 descendants cleared2024: 1 descendant cleared2019: 1 descendant cleared2020: 1 descendant clearedK950166 · Olympus KD-6G1-9Q Wire Guided Papillotomu Knife · Olympus America, Inc. · 1995 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 4 descendants4 generations forward: 3 descendants5 generations forward: 2 descendants K950166 · Olympus KD-6G1-9Q Wire Guided Papillotomu Knife · Olympus America, Inc. · 1995 · recalled0+5
  1. Root · 1 generation backK950166 Olympus KD-6G1-9Q Wire Guided Papillotomu KnifeOlympus America, Inc. · 1995 · Recalled
  2. This deviceK011149 Disposable Bending Cannula PR-233QThe Olympus Optical Co. · 2001
  3. Descendant · cites it directly · 11 of its ownK051504 Spyscope Access and Delivery CatheterBoston Scientific Corp · 2005
  4. Descendant · cites it directly · 10 of its ownK090170 Spyscope Access and Delivery CatheterBoston Scientific Corp · 2009
  5. Descendant · 2 generations on · 9 of its ownK142922 SpyGlass DS Direct Visualization SystemBoston Scientific Corporation · 2015 · Recalled
  6. Descendant · 3 generations on · 7 of its ownK181439 SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation · 2018
  7. Descendant · 4 generations on · 5 of its ownK183636 SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and…Boston Scientific Corporation · 2019

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2005: 12009: 12015: 12018: 12019: 12020: 12023: 12024: 12025: 12026: 3
2005high 3 (2026) · low 0 (2006)2026

Most influential descendants

Showing 5 of 12 · See all
  • K051504Spyscope Access and Delivery CatheterBoston Scientific Corp · 2005 · cites it directly11descendants
  • K090170Spyscope Access and Delivery CatheterBoston Scientific Corp · 2009 · cites it directly10descendants
  • K142922SpyGlass DS Direct Visualization SystemBoston Scientific Corporation · 2015 · 2 generations on9descendants
  • K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation · 2018 · 3 generations on7descendants
  • K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter…Boston Scientific Corporation · 2019 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K950166Olympus KD-6G1-9Q Wire Guided Papillotomu KnifeOlympus America, Inc.199510
0 (this device)K011149Disposable Bending Cannula PR-233QThe Olympus Optical Co.2001—
+1K051504Spyscope Access and Delivery CatheterBoston Scientific Corp2005—
+1K090170Spyscope Access and Delivery CatheterBoston Scientific Corp2009—
+2K142922SpyGlass DS Direct Visualization SystemBoston Scientific Corporation20151
+3K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation2018—
+4K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery…Boston Scientific Corporation2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200910
201510
201810
201910
202010
202310
202410
202510
202630
FIG. 1 — Lineage of K011149, 1995–2026Source: 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), 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 ODD? 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 ODD device

  1. #1 K250573 Single Use Cannula V…score 9.7 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K950729Olympus PR-23Q Disposable Cannula (Ball Tip)
Summary page 4
…e Cannula Classification: 21 CFR 876.1500 Endoscope and accessories 21 CFR 876.5010 Biliary catheter and accessories Predicate Device: PR-23Q PISPOSABLE BALL TIP CANNULA K950729 KD-6G WIRE GUIDED PAPILLOTOMY KNIVES K950166 JC o7 g fl,:“,,‘zali—' The subject device is a cannula which has a…
Olympus America, Inc.19951
*K950166Olympus KD-6G1-9Q Wire Guided Papillotomu Knife
Summary page 4
…scope and accessories 21 CFR 876.5010 Biliary catheter and accessories Predicate Device: PR-23Q PISPOSABLE BALL TIP CANNULA K950729 KD-6G WIRE GUIDED PAPILLOTOMY KNIVES K950166 JC o7 g fl,:“,,‘zali—' The subject device is a cannula which has a bending function (angle wire), to be used in a…
Olympus America, Inc.199510

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K051504Spyscope Access and Delivery CatheterBoston Scientific Corp200511
K090170Spyscope Access and Delivery CatheterBoston Scientific Corp200910

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?

  • 2 of the 2 ancestors have a recall of any class.
  • Of its descendants, K051504 (Boston Scientific Corp, 2005) has gone furthest, with 11 descendants of its own.

How does its category compare?

All ODD devices

ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ODD

1in 2025

2007: 12018: 12020: 12025: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODD

Too few ODD 510(k)s in any year since 2007 to give a median.

Recalls per year · ODD

No recall names ODD since 2007.

Adverse event reports per year · ODD

4in 2025

2007: 12008: 92009: 262012: 22015: 12016: 22017: 22018: 132019: 52020: 112021: 82022: 112023: 152024: 122025: 4
2007high 26 (2009) · low 0 (2010)2025

MAUDE reports naming product code ODD, 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
20071—01
20080—09
20090—026
20100—00
20110—00
20120—02
20130—00
20140—00
20150—01
20160—02
20170—02
20181—013
20190—05
20201—011
20210—08
20220—011
20230—015
20240—012
20251—04
20260—0—

What is it indicated for?

This instrument has been designed to be used with an Olympus endoscope to inject contrast medium in the biliary and pancreatic ducts, although it is not designed for the deep insertion into the pancreatic duct.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from The Olympus Optical Co.

22 FDA decisions under this applicant name. See the company

  • K032066Sonosurg SystemThe Olympus Optical Co. · 2003
  • K030194Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 20033 recalls
  • K021962Olympus Ultrasonic Surgical SystemThe Olympus Optical Co. · 2003
  • K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 200314 Class I recalls
  • K023272Disposable Aspiration Needle NA-200HThe Olympus Optical Co. · 20021 recall

Recent decisions in ODD

The ODD category page

  • K250573Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614MOlympus Medical Systems Corp. · 2025
  • K202583BioShield biopsy valve EUS - LinearSTERIS Corporation · 2020
  • K171989Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter…Wilson-Cook Medical, Inc. · 2018
  • K070420Bioshield-Ercp Biopsy Valve, Model 00711138United States Endoscopy Group, Inc. · 20071 recall
  • K010993Alien RX Micro Cannula, Model 4530Boston Scientific Corp · 2001

https://510kreport.com/device/K011149 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011149: Disposable Bending Cannula PR-233Q.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011149

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026