510(k) Report

510(k) · Cleared

Cleared

Ultra-VU Angioscope

K902329510(k) TraditionalCleared Aug 22, 199090-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

Angiolaz, Inc. · LYK Angioscope

Cleared on Aug 22, 1990 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 30 devices in its family, counting itself, has a Class I recall. 29 later devices descend from it.

Decided
Aug 22, 1990
Review
90 days
Class
Class II
Product code
LYK
Recalls
None
Predicates
0

29 later devices descend from it, 1 citing it directly. 1 of the 30 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2008: 2 descendants cleared2018: 2 descendants cleared, 1 with a Class I recall12011: 1 descendant cleared2026: 2 descendants cleared2013: 4 descendants cleared2012: 1 descendant cleared2014: 1 descendant cleared2015: 3 descendants cleared2019: 4 descendants cleared2017: 3 descendants cleared2024: 1 descendant cleared2025: 1 descendant cleared2022: 1 descendant cleared2020: 1 descendant cleared2023: 1 descendant cleared2021: 1 descendant cleared1990200020102020
  1. This deviceK902329 Ultra-VU AngioscopeAngiolaz, Inc. · 1990
  2. Descendant · cites it directly · 28 of its ownK071554 Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · Recalled
  3. Descendant · 2 generations on · 25 of its ownK082229 S5/S5I Series Intravascular Imaging and Pressure System, Combomap…Volcano Corporation · 2008 · Recalled
  4. Descendant · 3 generations on · 24 of its ownK111706 Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · Recalled
  5. Descendant · 4 generations on · 21 of its ownK123898 Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · Recalled
  6. Descendant · 5 generations on · 18 of its ownK133323 Volcano Ifr ModalityVolcano Corporation · 2014

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2008: 22011: 12012: 12013: 42014: 12015: 32017: 32018: 22019: 42020: 12021: 12022: 12023: 12024: 12025: 12026: 2
2008high 4 (2013) · low 0 (2009)2026

Class I recalls in this family

  • K172258 Novasight Hybrid System2 generations on · 2018

Most influential descendants

Showing 5 of 29 · See all
  • K071554Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 2008 · cites it directly28descendants
  • K082229S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow SystemVolcano Corporation · 2008 · 2 generations on25descendants
  • K111706Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation · 2011 · 3 generations on24descendants
  • K123898Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation · 2013 · 4 generations on21descendants
  • K133323Volcano Ifr ModalityVolcano Corporation · 2014 · 5 generations on18descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K902329Ultra-VU AngioscopeAngiolaz, Inc.1990—
+1K071554Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation20082
+2K082229S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and…Volcano Corporation20083
+3K111706Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation20111
+4K123898Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation201310
+5K133323Volcano Ifr ModalityVolcano Corporation2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
201110
201210
201340
201410
201530
201730
201821
201940
202010
202110
202210
202310
202410
202510
202620
FIG. 1 — Lineage of K902329, 1990–2026Source: 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.

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 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? (29)

See all 29

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

NumberDeviceApplicantDecidedDescendants
K071554Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation200828

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.

  • K172258Novasight Hybrid SystemConavi Medical, Inc. · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K071554 (Volcano Corporation, 2008) has gone furthest, with 28 descendants 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 Angiolaz, Inc.

10 FDA decisions under this applicant name. See the company

  • K994362Headlamp HL2000.Angiolaz, Inc. · 2000
  • K99244750 W Metal Halide Illuminator, Ves 0501.Angiolaz, Inc. · 1999
  • K982397Ves 3001-M Complete Video Endoscopic SystemAngiolaz, Inc. · 1998
  • K982409VES 1501-MAngiolaz, Inc. · 1998
  • K981819Angiolaz Ves-1CAMAngiolaz, Inc. · 1998

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/K902329 · printed Nov 6, 2026

Cite this page

510(k) Report. “K902329: Ultra-VU Angioscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902329

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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