510(k) · Cleared
ClearedEndoscope Position Marking Probe,Endoscope Position Detecting Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · PGU Spatial Imaging For Display Of Endoscope Position
Cleared on Mar 7, 2014 as substantially equivalent to K002749 (The Olympus Optical Co., 2000) and 1 other predicate after a 67-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Mar 7, 2014
- Review
- 67 days
- Class
- Class II
- Product code
- PGU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002749 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK002749 Endoscope Contour Detection Device, Model 3DX45 and Colonoscope…The Olympus Optical Co. · 2000
- 1 generation backK103312 UPD-Y0003Olympus Medical Systems Corporation · 2011
- This deviceK134026 Endoscope Position Marking Probe,Endoscope Position Detecting UnitOlympus Medical Systems Corp. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002749 | Endoscope Contour Detection Device, Model 3DX45 and Colonoscope, Model… | The Olympus Optical Co. | 2000 | — |
| −1 | K103312 | UPD-Y0003 | Olympus Medical Systems Corporation | 2011 | — |
| 0 (this device) | K134026 | Endoscope Position Marking Probe,Endoscope Position Detecting Unit | Olympus Medical Systems Corp. | 2014 | — |
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 PGU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002749 | Endoscope Contour Detection Device, Model 3DX45 and Colonoscope, Model XCF-Q140L/13DSummary page 2…odel name .Applicant . j 510 (k) No. Probe XBO1-657-6 Olympus Optical Co., Ltd. K002749 UPD-3 - ~50k o Model name… | 2000 |
| * | K103312 | UPD-Y0003Summary page 2…Model name %Applicaht 0k o- ENDOSCOPE POSITION OLYMPUS MEDICAL K103312 DETECTING UNIT SYSTEMS CORP. U PD-Y0003 ______ ____… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 10.4 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K002749.
How does its category compare?
All PGU devicesPGU Spatial Imaging For Display Of Endoscope Position: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PGU
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · PGU
Too few PGU 510(k)s in any year since 2007 to give a median.
Recalls per year · PGU
No recall names PGU since 2007.
Adverse event reports per year · PGU
2in 2023
MAUDE reports naming product code PGU, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This instrument has been designed to be used with an Olympus endoscope and the endoscope position detecting unit for detection and display of the location and/or shape of the inserted endoscope.
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 and enteroscopy except as follows:
Patients with a critical active implantable device such as a pacemaker and
an implantable cardioverter defibrillator
Pregnant women
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K134026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K134026: Endoscope Position Marking Probe,Endoscope Position Detecting Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K134026
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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