510(k) Report

510(k) · Cleared

Cleared

Olympus GF-UM3/EU-M3

K882061510(k) TraditionalCleared Nov 15, 1988183-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 Corp. · GDB Endoscope, Fiber Optic

Cleared on Nov 15, 1988 after a 183-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 of the 150 devices in its family, counting itself, have a Class I recall. 149 later devices descend from it.

Decided
Nov 15, 1988
Review
183 days
Class
Class II
Product code
GDB
Recalls
None
Predicates
0

149 later devices descend from it, 3 citing it directly. 6 of the 150 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 1998: 5 descendants cleared1996: 1 descendant cleared2001: 2 descendants cleared2000: 3 descendants cleared2002: 1 descendant cleared2004: 3 descendants cleared2007: 3 descendants cleared2023: 8 descendants cleared, 1 with a Class I recall12009: 10 descendants cleared2003: 1 descendant cleared2006: 2 descendants cleared2008: 5 descendants cleared2005: 4 descendants cleared2012: 11 descendants cleared2011: 4 descendants cleared2014: 10 descendants cleared2010: 4 descendants cleared2026: 6 descendants cleared2016: 7 descendants cleared2013: 1 descendant cleared2020: 7 descendants cleared, 1 with a Class I recall12025: 13 descendants cleared, 1 with a Class I recall12015: 6 descendants cleared2019: 10 descendants cleared, 1 with a Class I recall12017: 5 descendants cleared2018: 7 descendants cleared2022: 2 descendants cleared2021: 3 descendants cleared2024: 5 descendants cleared, 2 with a Class I recall21990200020102020
  1. This deviceK882061 Olympus GF-UM3/EU-M3Olympus Corp. · 1988
  2. Descendant · cites it directly · 142 of its ownK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
  3. Descendant · 2 generations on · 73 of its ownK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
  4. Descendant · cites it directly · 67 of its ownK982610 Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary…Olympus Optical, Co. · 1998
  5. Descendant · 2 generations on · 60 of its ownK011886 Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera…Olympus America, Inc. · 2001 · Recalled
  6. Descendant · 2 generations on · 59 of its ownK010591 Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · Recalled

Showing 5 of 149 descendants. See all descendants

Descendants cleared per year

1996: 11998: 52000: 32001: 22002: 12003: 12004: 32005: 42006: 22007: 32008: 52009: 102010: 42011: 42012: 112013: 12014: 102015: 62016: 72017: 52018: 72019: 102020: 72021: 32022: 22023: 82024: 52025: 132026: 6
1996high 13 (2025) · low 0 (1997)2026

Class I recalls in this family

  • K193517 ViziShot 2 FLEX7 generations on · 2020
  • K190106 Intra-Operative Positioning System; Simple Curve…12 generations on · 2019
  • K242133 Intra-Operative Positioning System (IOPS®)…13 generations on · 2024
  • K241243 Intra-Operative Positioning System (IOPS®)…13 generations on · 2024

Most influential descendants

Showing 5 of 149 · See all
  • K982323Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial UseOlympus America, Inc. · 1998 · cites it directly142descendants
  • K042438Superdimension/BronchusSuperdimension, Ltd. · 2004 · 2 generations on73descendants
  • K982610Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract)Olympus Optical, Co. · 1998 · cites it directly67descendants
  • K011886Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic…Olympus America, Inc. · 2001 · 2 generations on60descendants
  • K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · 2 generations on59descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K882061Olympus GF-UM3/EU-M3Olympus Corp.1988—
+1K982323Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for…Olympus America, Inc.1998—
+2K042438Superdimension/BronchusSuperdimension, Ltd.20041
+1K982610Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary…Olympus Optical, Co.1998—
+2K011886Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic…Olympus America, Inc.20011
+2K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd.20012

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199850
200030
200120
200210
200310
200430
200540
200620
200730
200850
2009100
201040
201140
2012110
201310
2014100
201560
201670
201750
201870
2019101
202071
202130
202220
202381
202452
2025131
202660
FIG. 1 — Lineage of K882061, 1988–2026Source: 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.

6 devices in this family have a Class I recall. 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
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? (149)

See all 149

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

NumberDeviceApplicantDecidedDescendants
K982323Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial UseOlympus America, Inc.1998142
K982610Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract)Olympus Optical, Co.199867
K961048Olympus MH-246R Balloon SheathOlympus America, Inc.19965

Has anything in its family been recalled? (6 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.

  • K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
  • K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 12 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
  • K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 13 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
  • K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 13 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
  • K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 13 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
  • K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 13 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

Nearest 5 of 6; all are on the web page.

What does this lineage say?

  • Of its descendants, K982323 (Olympus America, Inc., 1998) has gone furthest, with 142 descendants of its own.

How does its category compare?

All GDB devices

GDB Endoscope, Fiber Optic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GDB

FDA has decided no GDB device since 2007.

Median 510(k) review, days · GDB

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

Recalls per year · GDB

No recall names GDB since 2007.

Adverse event reports per year · GDB

1in 2020

2010: 32011: 32012: 12013: 12017: 12020: 1
2007high 3 (2010) · low 0 (2007)2025

MAUDE reports naming product code GDB, 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
20070—00
20080—00
20090—00
20100—03
20110—03
20120—01
20130—01
20140—00
20150—00
20160—00
20170—01
20180—00
20190—00
20200—01
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Olympus Corp.

142 FDA decisions under this applicant name. See the company

  • K915402EW-10 and EW-20Olympus Corp. · 1995
  • K933200Olympus PBD StentsOlympus Corp. · 19954 recalls
  • K942338Olympus PF-8P Oes Pancreato Fiberscope and AccessoriesOlympus Corp. · 1994
  • K931763HF-Resection Electrode, Loop W/Runner Endos/AccessOlympus Corp. · 1994
  • K934835FlovalOlympus Corp. · 1994

Recent decisions in GDB

The GDB category page

  • K032283Designs for Vision Fiberoptic LightDesigns For Vision, Inc. · 2003
  • K961536FlexscopeMatrix Medica, Inc. · 1996
  • K935818EndoscopeCuda Products Co. · 1994
  • K855151Fritch Ophthalmic EndoscopeRegtec · 1986
  • K843900Focuscope Universal SystemMedical Diagnostics, Ca. · 1984

https://510kreport.com/device/K882061 · printed Nov 6, 2026

Cite this page

510(k) Report. “K882061: Olympus GF-UM3/EU-M3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K882061

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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