510(k) Report

510(k) · Cleared

Recalled · Class II · 2021

Olympus PR-23Q Disposable Cannula (Ball Tip)

K950729510(k) TraditionalCleared Mar 17, 199529-day reviewClass II21 CFR 876.1500Recalls 1

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

Olympus America, Inc. · ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula

Cleared on Mar 17, 1995 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it. It has been recalled once.

Decided
Mar 17, 1995
Review
29 days
Class
Class II
Product code
ODD
Recalls
1
Predicates
0

13 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2005: 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 cleared1995200020052010201520202025
  1. This deviceK950729 Olympus PR-23Q Disposable Cannula (Ball Tip)Olympus America, Inc. · 1995
  2. Descendant · cites it directly · 12 of its ownK011149 Disposable Bending Cannula PR-233QThe Olympus Optical Co. · 2001
  3. Descendant · 2 generations on · 11 of its ownK051504 Spyscope Access and Delivery CatheterBoston Scientific Corp · 2005
  4. Descendant · 2 generations on · 10 of its ownK090170 Spyscope Access and Delivery CatheterBoston Scientific Corp · 2009
  5. Descendant · 3 generations on · 9 of its ownK142922 SpyGlass DS Direct Visualization SystemBoston Scientific Corporation · 2015 · Recalled
  6. Descendant · 4 generations on · 7 of its ownK181439 SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation · 2018

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2001: 12005: 12009: 12015: 12018: 12019: 12020: 12023: 12024: 12025: 12026: 3
2001high 3 (2026) · low 0 (2002)2026

Most influential descendants

Showing 5 of 13 · See all
  • K011149Disposable Bending Cannula PR-233QThe Olympus Optical Co. · 2001 · cites it directly12descendants
  • K051504Spyscope Access and Delivery CatheterBoston Scientific Corp · 2005 · 2 generations on11descendants
  • K090170Spyscope Access and Delivery CatheterBoston Scientific Corp · 2009 · 2 generations on10descendants
  • K142922SpyGlass DS Direct Visualization SystemBoston Scientific Corporation · 2015 · 3 generations on9descendants
  • K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation · 2018 · 4 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950729Olympus PR-23Q Disposable Cannula (Ball Tip)Olympus America, Inc.1995—
+1K011149Disposable Bending Cannula PR-233QThe Olympus Optical Co.2001—
+2K051504Spyscope Access and Delivery CatheterBoston Scientific Corp2005—
+2K090170Spyscope Access and Delivery CatheterBoston Scientific Corp2009—
+3K142922SpyGlass DS Direct Visualization SystemBoston Scientific Corporation20151
+4K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200510
200910
201510
201810
201910
202010
202310
202410
202510
202630
FIG. 1 — Lineage of K950729, 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), 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?

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

What descends from it? (13)

See all 13

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K011149Disposable Bending Cannula PR-233QThe Olympus Optical Co.200112

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 4, 2021Class IIZ-0969-2021Under Investigation by firmInspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K011149 (The Olympus Optical Co., 2001) has gone furthest, with 12 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—

More from Olympus America, Inc.

149 FDA decisions under this applicant name. See the company

  • K111788Endoeye HD IIOlympus America, Inc. · 20122 recalls
  • K081615Olympus Cea - Carcinoembryonic AntigenOlympus America, Inc. · 2009
  • K073489Olympus Iga ReagentOlympus America, Inc. · 20081 recall
  • K073490Olympus Igg ReagentOlympus America, Inc. · 2008
  • K073487Olympus Igm ReagentOlympus America, Inc. · 20081 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
  • K011149Disposable Bending Cannula PR-233QThe Olympus Optical Co. · 2001

https://510kreport.com/device/K950729 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950729: Olympus PR-23Q Disposable Cannula (Ball Tip).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950729

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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