510(k) Report

510(k) · Cleared

Cleared

Olympus PF-18 & PF-25 Ultrathin Angioscope

K860858510(k) TraditionalCleared Nov 20, 1986258-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. · LYK Angioscope

Cleared on Nov 20, 1986 after a 258-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Nov 20, 1986
Review
258 days
Class
Class II
Product code
LYK
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2006: 1 descendant cleared1990200020102020
  1. This deviceK860858 Olympus PF-18 & PF-25 Ultrathin AngioscopeOlympus Corp. · 1986
  2. Descendant · cites it directly · 1 of its ownK050808 Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc. · 2005
  3. Descendant · cites it directly · 0 of its ownK062340 Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc. · 2006

Most influential descendants

Showing 2 of 2 · See all
  • K050808Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc. · 2005 · cites it directly1descendant
  • K062340Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K860858Olympus PF-18 & PF-25 Ultrathin AngioscopeOlympus Corp.1986—
+1K050808Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc.2005—
+1K062340Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
FIG. 1 — Lineage of K860858, 1986–2006Source: 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.

Planning a device in LYK? 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 LYK device

  1. #1 K253842 Vena MicroAngioscope™ Systemscore 10.8 · 1 generation · no Class I recall
  2. #2 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K050808Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc.20051
K062340Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc.20060

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, K050808 (Cardio-Optics, Inc., 2005) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LYK devices

LYK Angioscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYK

1in 2025

2025: 12026 (partial year): 1
2007high 1 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYK

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

Recalls per year · LYK

No recall names LYK since 2007.

Adverse event reports per year · LYK

1in 2024

2010: 12013: 22017: 12024: 1
2007high 2 (2013) · low 0 (2007)2025

MAUDE reports naming product code LYK, 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—01
20110—00
20120—00
20130—02
20140—00
20150—00
20160—00
20170—01
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—01
20251—00
20261—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 LYK

The LYK category page

  • K253842Vena MicroAngioscope™ SystemVena Medical Holdings Corp · 2026
  • K251767Vena MicroAngioscope™ SystemVena Medical Holdings Corp · 2025
  • K062340Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc. · 2006
  • K050808Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc. · 2005
  • K011793Ksea FiberscopeKARL STORZ Endoscopy-America, Inc. · 2002

https://510kreport.com/device/K860858 · printed Nov 6, 2026

Cite this page

510(k) Report. “K860858: Olympus PF-18 & PF-25 Ultrathin Angioscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K860858

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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