510(k) · Cleared

Cleared

UPD-Y0003

K103312510(k) TraditionalCleared May 12, 2011183-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

Olympus Medical Systems Corporation · FDF Colonoscope And Accessories, Flexible/Rigid

Cleared on May 12, 2011 as substantially equivalent to K002749 (The Olympus Optical Co., 2000) after a 183-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.

Decided: May 12, 2011
Review: 183 days
Class: Class II
Product code: FDF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K002749 (2000). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK002749 Endoscope Contour Detection Device, Model 3DX45 and Colonoscope…The Olympus Optical Co. · 2000
This deviceK103312 UPD-Y0003Olympus Medical Systems Corporation · 2011
Descendant · cites it directly · 0 of its ownK134026 Endoscope Position Marking Probe,Endoscope Position Detecting UnitOlympus Medical Systems Corp. · 2014

Most influential descendants

Showing 1 of 1 · See all

K134026Endoscope Position Marking Probe,Endoscope Position Detecting UnitOlympus Medical Systems Corp. · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002749	Endoscope Contour Detection Device, Model 3DX45 and Colonoscope, Model…	The Olympus Optical Co.	2000	—
0 (this device)	K103312	UPD-Y0003	Olympus Medical Systems Corporation	2011	—
+1	K134026	Endoscope Position Marking Probe,Endoscope Position Detecting Unit	Olympus Medical Systems Corp.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K103312, 2000–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 FDF? 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 FDF device

#1 K230332 Ambu® aScope™ Colon; Ambu® aBox™ 2score 20.1 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K002749	Endoscope Contour Detection Device, Model 3DX45 and Colonoscope, Model XCF-Q140L/13D Summary page 2 …of this No. ENDOSCOPE POSITION DETECTING jEndoscope Contour Detection Device K002749 UNIT UPD-Y0003 3DX45 ____ 4 Device Description <Devic…	The Olympus Optical Co.	2000	—

Also cleared against K002749: 2 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K134026	Endoscope Position Marking Probe,Endoscope Position Detecting Unit	Olympus Medical Systems Corp.	2014	0

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?

Its one ancestor has no recall.
Of its descendants, K134026 (Olympus Medical Systems Corp., 2014) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K002749.

How does its category compare?

All FDF devices

FDF Colonoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · FDF

4in 2025

2007high 7 (2012) · low 2 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FDF

194in 2025

2007high 250 (2020) · low 30 (2021)2026

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

Recalls per year · FDF

8in 2023

2007high 8 (2023) · low 0 (2007)2026

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

Adverse event reports per year · FDF

17,231in 2025

2007high 17,231 (2025) · low 48 (2010)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	4	70	0	81
2008	2	—	0	68
2009	6	91	0	83
2010	4	101	0	48
2011	2	—	0	77
2012	7	241	0	88
2013	2	—	0	63
2014	6	164	0	60
2015	2	—	1	100
2016	7	98	1	170
2017	4	36	0	370
2018	7	101	0	388
2019	4	56	0	417
2020	4	250	1	687
2021	3	30	0	2,444
2022	5	147	0	8,345
2023	6	203	8	11,748
2024	2	—	0	12,128
2025	4	194	0	17,231
2026	5	147	0	—

What is it indicated for?

This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient.

Patients who require colonoscopy except as follows:

-Patients with a pacemaker

-Pregnant women

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103312 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103312: UPD-Y0003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103312

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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