Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

VOLUMEVIEW

Model VLVFC5205 · Edwards Lifesciences LLC · DI 00690103183924

KRB — Probe, Thermodilution · Class II · 21 CFR 870.1915

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

13452019-10: 0 reports for this device; peer average 2.5/device2019-11: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1.5/device2020-11: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 2/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 4/device2021-05: 0 reports for this device; peer average 4/device2021-09: 0 reports for this device; peer average 1.5/device2021-10: 0 reports for this device; peer average 1.5/device2021-12: 0 reports for this device; peer average 2/device2022-03: 0 reports for this device; peer average 2/device2022-09: 0 reports for this device; peer average 2.67/device2022-10: 0 reports for this device; peer average 2/device2022-11: 0 reports for this device; peer average 5/device2022-12: 0 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 2.5/device2023-05: 0 reports for this device; peer average 2/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 2/device2023-09: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 2/device2023-12: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 3.5/device2024-02: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 1.5/device2024-05: 0 reports for this device; peer average 4/device2024-07: 0 reports for this device; peer average 4/device2024-08: 0 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 1.25/device2024-11: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 3/device2025-02: 0 reports for this device; peer average 2/device2025-03: 0 reports for this device; peer average 2.33/device2025-04: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 1.75/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 1.5/device2025-11: 0 reports for this device; peer average 4/device2025-12: 0 reports for this device; peer average 1.33/device2026-01: 0 reports for this device; peer average 3/device2026-03: 0 reports for this device; peer average 1.5/device2026-04: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 2/device1011020709101112010203040509101203091011120102050708091012010203040507080910111201020304050607081011120103040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-1002.5
2019-1102
2020-0202
2020-0702
2020-0901
2020-1001.5
2020-1101
2020-1202
2021-0101
2021-0202
2021-0302
2021-0404
2021-0504
2021-0901.5
2021-1001.5
2021-1202
2022-0302
2022-0902.67
2022-1002
2022-1105
2022-1202
2023-0102
2023-0202.5
2023-0502
2023-0702
2023-0802
2023-0902
2023-1002
2023-1202
2024-0103.5
2024-0202
2024-0302
2024-0401.5
2024-0504
2024-0704
2024-0802
2024-0902
2024-1001.25
2024-1102
2024-1201
2025-0103
2025-0202
2025-0302.33
2025-0401
2025-0502
2025-0601.75
2025-0701
2025-0802
2025-1001.5
2025-1104
2025-1201.33
2026-0103
2026-0301.5
2026-0401
2026-0501
2026-0602
This device (reports/month)Average device in KRB (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K100739 — cites (transitively): K072364 (d1) — cited as predicate by K110167, K113565

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Edwards Lifesciences LLC

  • Warning Letter 2013-05-24 Edwards Lifesciences, LLC
  • Warning Letter 2013-05-24 Edwards Lifesciences, LLC
  • Warning Letter 2010-03-01 Edwards Lifesciences, LLC
  • Warning Letter 2010-03-01 Edwards Lifesciences, LLC
  • NAI 2024-08-15 Edwards Lifesciences, LLC · 0 citations
  • NAI 2024-08-15 Edwards Lifesciences, LLC · 0 citations
  • NAI 2022-12-06 Edwards Lifesciences, LLC · 0 citations
  • NAI 2022-12-06 Edwards Lifesciences, LLC · 0 citations
  • NAI 2021-11-19 Edwards Lifesciences, LLC · 0 citations
  • NAI 2021-11-19 Edwards Lifesciences, LLC · 0 citations
  • NAI 2019-08-19 Edwards Lifesciences, LLC · 0 citations
  • NAI 2019-08-19 Edwards Lifesciences, LLC · 0 citations
  • VAI 2019-06-14 Edwards Lifesciences, LLC · 3 citations
  • VAI 2019-06-14 Edwards Lifesciences, LLC · 3 citations
  • NAI 2018-02-01 Edwards Lifesciences, LLC · 0 citations
  • NAI 2018-02-01 Edwards Lifesciences, LLC · 0 citations
  • NAI 2017-07-14 Edwards Lifesciences (Singapore) Pte. Ltd · 0 citations
  • VAI 2016-05-20 Edwards Lifesciences, LLC · 3 citations
  • VAI 2016-05-20 Edwards Lifesciences, LLC · 3 citations
  • VAI 2016-02-12 Edwards Lifesciences, LLC · 0 citations
  • VAI 2016-02-12 Edwards Lifesciences, LLC · 0 citations
  • NAI 2015-12-17 Edwards Lifesciences (Singapore) Pte. Ltd · 0 citations
  • VAI 2015-11-20 Edwards Lifesciences, LLC · 5 citations
  • VAI 2015-11-20 Edwards Lifesciences, LLC · 3 citations