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VOLUMEVIEW

Model VLV8R5 · Edwards Lifesciences LLC · DI 07460691950481

DRS — Transducer, Blood-Pressure, Extravascular · Class II · 21 CFR 870.2850

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

UDILibrary device dossier · generated 2026-09-14 · 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.

24572019-01: 0 reports for this device; peer average 3/device2019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 2/device2019-06: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 2/device2019-11: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 1.25/device2020-03: 0 reports for this device; peer average 2/device2020-04: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 1.33/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 1.5/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 2/device2021-05: 0 reports for this device; peer average 4/device2021-06: 0 reports for this device; peer average 3/device2021-07: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1.5/device2021-10: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 7/device2022-02: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 1.5/device2022-04: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 2.5/device2022-06: 0 reports for this device; peer average 2/device2022-07: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 2.33/device2022-10: 0 reports for this device; peer average 1.5/device2022-11: 0 reports for this device; peer average 3/device2022-12: 0 reports for this device; peer average 1.33/device2023-01: 0 reports for this device; peer average 1.6/device2023-02: 0 reports for this device; peer average 2.5/device2023-03: 0 reports for this device; peer average 2.33/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 2.6/device2023-06: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 1.75/device2023-08: 0 reports for this device; peer average 1.5/device2023-09: 0 reports for this device; peer average 1.25/device2023-10: 0 reports for this device; peer average 2.33/device2023-11: 0 reports for this device; peer average 2.4/device2023-12: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 1.88/device2024-02: 0 reports for this device; peer average 2.33/device2024-03: 0 reports for this device; peer average 1.33/device2024-04: 0 reports for this device; peer average 1.73/device2024-05: 0 reports for this device; peer average 5/device2024-06: 0 reports for this device; peer average 3.3/device2024-07: 0 reports for this device; peer average 3.33/device2024-08: 0 reports for this device; peer average 2.25/device2024-09: 0 reports for this device; peer average 1.5/device2024-10: 0 reports for this device; peer average 1.5/device2024-11: 0 reports for this device; peer average 1.83/device2024-12: 0 reports for this device; peer average 4/device2025-01: 0 reports for this device; peer average 2.25/device2025-02: 0 reports for this device; peer average 2.63/device2025-03: 0 reports for this device; peer average 1.83/device2025-04: 0 reports for this device; peer average 1.38/device2025-05: 0 reports for this device; peer average 2.25/device2025-06: 0 reports for this device; peer average 1.6/device2025-07: 0 reports for this device; peer average 1.25/device2025-08: 0 reports for this device; peer average 2.2/device2025-09: 0 reports for this device; peer average 2.25/device2025-10: 0 reports for this device; peer average 1.5/device2025-11: 0 reports for this device; peer average 2.4/device2025-12: 0 reports for this device; peer average 1.1/device2026-01: 0 reports for this device; peer average 4.8/device2026-02: 0 reports for this device; peer average 6.83/device2026-03: 0 reports for this device; peer average 2.8/device2026-04: 0 reports for this device; peer average 2.07/device2026-05: 0 reports for this device; peer average 2.2/device2026-06: 0 reports for this device; peer average 2.25/device01020304060809101102030406070910111201020304050607091011120102030405060709101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103
2019-0201
2019-0302
2019-0402
2019-0601
2019-0801
2019-0902
2019-1002
2019-1102
2020-0201.25
2020-0302
2020-0401
2020-0601
2020-0702
2020-0901.33
2020-1001.5
2020-1101
2020-1201.5
2021-0101
2021-0202
2021-0302
2021-0402
2021-0504
2021-0603
2021-0701
2021-0901.5
2021-1002
2021-1101
2021-1202
2022-0107
2022-0203
2022-0301.5
2022-0401
2022-0502.5
2022-0602
2022-0701
2022-0902.33
2022-1001.5
2022-1103
2022-1201.33
2023-0101.6
2023-0202.5
2023-0302.33
2023-0401
2023-0502.6
2023-0601
2023-0701.75
2023-0801.5
2023-0901.25
2023-1002.33
2023-1102.4
2023-1202
2024-0101.88
2024-0202.33
2024-0301.33
2024-0401.73
2024-0505
2024-0603.3
2024-0703.33
2024-0802.25
2024-0901.5
2024-1001.5
2024-1101.83
2024-1204
2025-0102.25
2025-0202.63
2025-0301.83
2025-0401.38
2025-0502.25
2025-0601.6
2025-0701.25
2025-0802.2
2025-0902.25
2025-1001.5
2025-1102.4
2025-1201.1
2026-0104.8
2026-0206.83
2026-0302.8
2026-0402.07
2026-0502.2
2026-0602.25
This device (reports/month)Average device in DRS, 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

K152980 — cited as predicate by K180881, K183646, K190205, K203224, K231248, K242909

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