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12 uPAT Probes for Watch-PAT200U

Model 12 uPAT Probes for Watch-PAT200U · ITAMAR MEDICAL LTD · DI 07290109222011

MNR — Ventilatory Effort Recorder · Class II · 21 CFR 868.2375

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.

25792020-03: 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 1/device2021-03: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 2/device2021-12: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 2/device2022-05: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 4/device2024-03: 0 reports for this device; peer average 2/device2024-08: 0 reports for this device; peer average 9/device2025-01: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 2/device2025-03: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 6/device2025-10: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 6/device2025-12: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 6/device0306070310120105090102070812010308010203050710111201
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0301
2020-0601
2020-0701
2021-0302
2021-1002
2021-1202
2022-0102
2022-0501
2022-0901
2023-0101
2023-0201
2023-0702
2023-0801
2023-1201
2024-0104
2024-0302
2024-0809
2025-0102
2025-0202
2025-0302
2025-0502
2025-0706
2025-1002
2025-1106
2025-1202
2026-0106
This device (reports/month)Average device in MNR (reports/device/month)

Regulatory clearances

  • K180775 SESE 2018-08-17 (k number procode)

Predicate lineage

K133859 — cited as predicate by K153070, K161579

K153070 — cites (transitively): K080427 (d1), K122516 (d1), K133859 (d1), K041904 (d2), K073682 (d2)

K161579 — cites (transitively): K122516 (d1), K133859 (d1), K041904 (d2), K073682 (d2) — cited as predicate by K180775, K191031, K203839

K180775 — cites (transitively): K161579 (d1), K122516 (d2), K133859 (d2), K041904 (d3), K073682 (d3) — cited as predicate by K183559, K222331, K231546

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

Manufacturer compliance record — ITAMAR MEDICAL LTD

  • VAI 2019-12-19 Itamar Medical Ltd. · 1 citations
  • VAI 2019-12-19 Itamar Medical Ltd. · 1 citations
  • VAI 2011-01-13 Itamar Medical Ltd. · 0 citations
  • VAI 2011-01-13 Itamar Medical Ltd. · 0 citations