510(k) Report

510(k) · Cleared

Cleared

Olympus GF-UM2/EU-M2

K872027510(k) TraditionalCleared Aug 17, 198783-day reviewClass II21 CFR 892.1560

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

Olympus Corp. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Aug 17, 1987 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
Aug 17, 1987
Review
83 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
0

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

Descendants, by year cleared 1996: 1 descendant cleared1998: 3 descendants cleared2000: 2 descendants cleared1990200020102020
  1. This deviceK872027 Olympus GF-UM2/EU-M2Olympus Corp. · 1987
  2. Descendant · cites it directly · 5 of its ownK961048 Olympus MH-246R Balloon SheathOlympus America, Inc. · 1996
  3. Descendant · 2 generations on · 1 of its ownK982733 Olympus MH-246R Balloon Sheath, for Bronchial UseThe Olympus Optical Co. · 1998
  4. Descendant · 2 generations on · 1 of its ownK982734 Olympus MH-246R Balloon Sheath, for Urinary Tract UseThe Olympus Optical Co. · 1998
  5. Descendant · 3 generations on · 0 of its ownK994106 Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary…Olympus America, Inc. · 2000
  6. Descendant · 3 generations on · 0 of its ownK994069 Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary…Olympus America, Inc. · 2000

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1996: 11998: 32000: 2
1996high 3 (1998) · low 0 (1997)2026

Most influential descendants

Showing 5 of 6 · See all
  • K961048Olympus MH-246R Balloon SheathOlympus America, Inc. · 1996 · cites it directly5descendants
  • K982733Olympus MH-246R Balloon Sheath, for Bronchial UseThe Olympus Optical Co. · 1998 · 2 generations on1descendant
  • K982734Olympus MH-246R Balloon Sheath, for Urinary Tract UseThe Olympus Optical Co. · 1998 · 2 generations on1descendant
  • K994106Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Bronchial UseOlympus America, Inc. · 2000 · 3 generations on0descendants
  • K994069Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Urinary UseOlympus America, Inc. · 2000 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K872027Olympus GF-UM2/EU-M2Olympus Corp.1987—
+1K961048Olympus MH-246R Balloon SheathOlympus America, Inc.1996—
+2K982733Olympus MH-246R Balloon Sheath, for Bronchial UseThe Olympus Optical Co.1998—
+2K982734Olympus MH-246R Balloon Sheath, for Urinary Tract UseThe Olympus Optical Co.1998—
+3K994106Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for…Olympus America, Inc.2000—
+3K994069Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for…Olympus America, Inc.2000—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199830
200020
FIG. 1 — Lineage of K872027, 1987–2000Source: 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 IYO? 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 IYO device

  1. #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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? (6)

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

NumberDeviceApplicantDecidedDescendants
K961048Olympus MH-246R Balloon SheathOlympus America, Inc.19965

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?

  • Of its descendants, K961048 (Olympus America, Inc., 1996) has gone furthest, with 5 descendants of its own.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYO

7in 2025

2007: 202008: 142009: 132010: 152011: 112012: 152013: 172014: 142015: 192016: 102017: 192018: 142019: 132020: 112021: 152022: 52023: 112024: 102025: 72026 (partial year): 10
2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007: 17 days median2008: 36 days median2009: 79 days median2010: 113 days median2011: 69 days median2012: 68 days median2013: 50 days median2014: 63 days median2015: 46 days median2016: 36 days median2017: 72 days median2018: 56 days median2019: 59 days median2020: 57 days median2021: 64 days median2022: 190 days median2023: 177 days median2024: 220 days median2025: 171 days median2026 (partial year): 139 days median
2007high 220 (2024) · low 17 (2007)2026

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

Recalls per year · IYO

1in 2022

2007: 42008: 52009: 92010: 82012: 22013: 32014: 22015: 12018: 12019: 12021: 112022: 12026 (partial year): 1
2007high 11 (2021) · low 0 (2011)2026

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

Adverse event reports per year · IYO

485in 2025

2007: 392008: 202009: 272010: 202011: 582012: 782013: 4362014: 3042015: 2682016: 2542017: 2382018: 3682019: 5372020: 4982021: 6172022: 5112023: 5272024: 6402025: 485
2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, 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
20072017439
20081436520
20091379927
201015113820
20111169058
20121568278
201317503436
201414632304
201519461268
201610360254
201719720238
201814561368
201913591537
202011570498
2021156411617
202251901511
2023111770527
2024102200640
202571710485
2026101391—

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

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The IYO category page

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https://510kreport.com/device/K872027 · printed Nov 6, 2026

Cite this page

510(k) Report. “K872027: Olympus GF-UM2/EU-M2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K872027

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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