510(k) Report

510(k) · Cleared

Cleared

Angioscope

K934696510(k) TraditionalCleared Jan 18, 1994110-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

Intramed Laboratories, Inc. · LYK Angioscope

Cleared on Jan 18, 1994 after a 110-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 18, 1994
Review
110 days
Class
Class II
Product code
LYK
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K934696Source: FDA 510(k) database · 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 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?

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.

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 Intramed Laboratories, Inc.

14 FDA decisions under this applicant name. See the company

  • K953258Titanium Hemostatic ClipIntramed Laboratories, Inc. · 1996
  • K942457Graft Thrombectomy InstrumentsIntramed Laboratories, Inc. · 1995
  • K931792ArthroscopeIntramed Laboratories, Inc. · 1994
  • K925283ValvulotomeIntramed Laboratories, Inc. · 1994
  • K922114Endoscopic Retrieval BasketIntramed Laboratories, Inc. · 1992

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/K934696 · printed Nov 4, 2026

Cite this page

510(k) Report. “K934696: Angioscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K934696

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