510(k) Report

510(k) · Cleared

Cleared

Endoscope Contour Detection Device, Model 3DX45 and Colonoscope, Model XCF-Q140L/13D

K002749510(k) TraditionalCleared Dec 4, 200090-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. · FDF Colonoscope And Accessories, Flexible/Rigid

Cleared on Dec 4, 2000 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 61 devices in its family, counting itself, has a Class I recall. 60 later devices descend from it.

Decided
Dec 4, 2000
Review
90 days
Class
Class II
Product code
FDF
Recalls
None
Predicates
0

60 later devices descend from it, 3 citing it directly. 1 of the 61 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2011: 1 descendant cleared2012: 2 descendants cleared2014: 1 descendant cleared2013: 3 descendants cleared2024: 5 descendants cleared2019: 4 descendants cleared2015: 2 descendants cleared2017: 1 descendant cleared2022: 2 descendants cleared2020: 8 descendants cleared2021: 4 descendants cleared2018: 1 descendant cleared2023: 7 descendants cleared2025: 15 descendants cleared, 1 with a Class I recall12026: 4 descendants cleared200020052010201520202025
  1. This deviceK002749 Endoscope Contour Detection Device, Model 3DX45 and Colonoscope…The Olympus Optical Co. · 2000
  2. Descendant · cites it directly · 57 of its ownK112680 Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · Recalled
  3. Descendant · 2 generations on · 19 of its ownK123365 Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp. · 2013
  4. Descendant · 2 generations on · 19 of its ownK122831 Video System CenterOlympus Medical Systems Corp. · 2012
  5. Descendant · 3 generations on · 12 of its ownK163675 Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. · 2017
  6. Descendant · 3 generations on · 7 of its ownK150525 SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU…KARL STORZ Endoscopy-America, Inc. · 2015

Showing 5 of 60 descendants. See all descendants

Descendants cleared per year

2011: 12012: 22013: 32014: 12015: 22017: 12018: 12019: 42020: 82021: 42022: 22023: 72024: 52025: 152026: 4
2011high 15 (2025) · low 0 (2016)2026

Class I recalls in this family

  • K250862 Evis Exera Iii Bronchovideoscope (Olympus…4 generations on · 2025

Most influential descendants

Showing 5 of 60 · See all
  • K112680Evis Exera Iii Video SystemOlympus Medical Systems Corporation · 2012 · cites it directly57descendants
  • K123365Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp. · 2013 · 2 generations on19descendants
  • K122831Video System CenterOlympus Medical Systems Corp. · 2012 · 2 generations on19descendants
  • K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. · 2017 · 3 generations on12descendants
  • K150525SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 LinkKARL STORZ Endoscopy-America, Inc. · 2015 · 3 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002749Endoscope Contour Detection Device, Model 3DX45 and Colonoscope, Model…The Olympus Optical Co.2000—
+1K112680Evis Exera Iii Video SystemOlympus Medical Systems Corporation20126
+2K123365Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp.2013—
+2K122831Video System CenterOlympus Medical Systems Corp.2012—
+3K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc.2017—
+3K150525SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 LinkKARL STORZ Endoscopy-America, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201220
201330
201410
201520
201710
201810
201940
202080
202140
202220
202370
202450
2025151
202640
FIG. 1 — Lineage of K002749, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

1 device in this family has a Class I recall. 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. #1 K230332 Ambu® aScope™ Colon; Ambu® aBox™ 2score 20.1 · 8 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? (60)

See all 60

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

NumberDeviceApplicantDecidedDescendants
K112680Evis Exera Iii Video SystemOlympus Medical Systems Corporation201257
K103312UPD-Y0003Olympus Medical Systems Corporation20111
K134026Endoscope Position Marking Probe,Endoscope Position Detecting UnitOlympus Medical Systems Corp.20140

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K250862Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii Bronchovideoscope (Olympus BF-P190)…Olympus Medical Systems Corp. · 2025 · 4 generations on · ◆ in the 2025 descendants bar of FIG. 14 Class I recalls

What does this lineage say?

  • Of its descendants, K112680 (Olympus Medical Systems Corporation, 2012) has gone furthest, with 57 descendants of its own.

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.

FDA decisions per year · FDF

4in 2025

2007: 42008: 22009: 62010: 42011: 22012: 72013: 22014: 62015: 22016: 72017: 42018: 72019: 42020: 42021: 32022: 52023: 62024: 22025: 42026 (partial year): 5
2007high 7 (2012) · low 2 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FDF

194in 2025

2007: 70 days median2009: 91 days median2010: 101 days median2012: 241 days median2014: 164 days median2016: 98 days median2017: 36 days median2018: 101 days median2019: 56 days median2020: 250 days median2021: 30 days median2022: 147 days median2023: 203 days median2025: 194 days median2026 (partial year): 147 days median
2007high 250 (2020) · low 30 (2021)2026

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

Recalls per year · FDF

8in 2023

2015: 12016: 12020: 12023: 8
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

2007: 812008: 682009: 832010: 482011: 772012: 882013: 632014: 602015: 1002016: 1702017: 3702018: 3882019: 4172020: 6872021: 2,4442022: 8,3452023: 11,7482024: 12,1282025: 17,231
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007470081
20082—068
2009691083
20104101048
20112—077
20127241088
20132—063
20146164060
20152—1100
20167981170
20174360370
201871010388
20194560417
202042501687
202133002,444
2022514708,345
20236203811,748
20242—012,128
20254194017,231
202651470—

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 FDF

The FDF category page

  • K260503Triton 1 SystemNeptune Medical, Inc. · 2026
  • K261015Solo Scope Colonoscope SystemGi View, Ltd. · 2026
  • K261587Insufflation Retention Device (IRD) (11173-325-101)BPEndo, LLC · 2026
  • K260423Disposable Endoscopic Distal AttachmentsYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2026
  • K252457Disposable Distal End Tape HoodShanghai SeeGen Photoelectric Technology Co., Ltd. · 2026

https://510kreport.com/device/K002749 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002749: Endoscope Contour Detection Device, Model 3DX45 and Colonoscope, Model XCF-Q140L/13D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002749

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026