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1ST284-100 LuMon™ Belt Size 104

Model 1ST284-100 · SenTec AG · DI EIT11ST2841000

BZQ — Monitor, Breathing Frequency · Class II · 21 CFR 868.2375

QEB — Ventilatory Electrical Impedance Tomograph · Class II · 21 CFR 868.1505

UDILibrary device dossier · generated 2026-09-11 · 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.

12342021-09: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 1.5/device2025-04: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 1.5/device2025-10: 0 reports for this device; peer average 3.5/device2025-12: 0 reports for this device; peer average 1.5/device2026-03: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 2/device0910040509020406081012030406
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-0902
2021-1001
2024-0401
2024-0501
2024-0901
2025-0201.5
2025-0401
2025-0601
2025-0801.5
2025-1003.5
2025-1201.5
2026-0301
2026-0401
2026-0602
This device (reports/month)Average device in BZQ, QEB (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K243765 — cites (transitively): K113798 (d1), K222987 (d1), K093788 (d2), K183105 (d2), K193560 (d2), K203315 (d2), K212569 (d2), K070566 (d3), K073468 (d3), K173619 (d3), K051075 (d3), K052472 (d3), K062250 (d3), K080402 (d3), K092122 (d3), K092873 (d3), K100448 (d3), K100858 (d3), K110598 (d3), K111629 (d3), K112438 (d3), K113254 (d3), K120174 (d3), K130050 (d3), K130642 (d3), K131559 (d3), K133349 (d3), K142139 (d3), K142413 (d3), K143256 (d3), K152047 (d3), K153602 (d3), K161189 (d3), K162024 (d3), K162800 (d3), K170893 (d3), K172054 (d3), K173717 (d3), K181999 (d3), K183039 (d3), K183077 (d3), K190286 (d3), K170968 (d3), K202716 (d3), K203694 (d3), K032126 (d4), K063578 (d4), K962082 (d4), K030259 (d4), K992525 (d4), K111863 (d4), K053274 (d4), K081016 (d4), K091751 (d4), K101263 (d4), K111212 (d4), K113523 (d4), K030710 (d4), K103007 (d4), K130895 (d4), K112144 (d4), K113413 (d4), K123982 (d4), K140904 (d4), K101342 (d4), K111902 (d4), K132636 (d4), K151293 (d4), K160001 (d4), K160555 (d4), K160975 (d4), K110360 (d4), K131283 (d4), K142117 (d4), K162795 (d4), K112069 (d4), K161841 (d4), K060692 (d4), K172634 (d4), K180612 (d4), K181742 (d4), K030941 (d4), K061439 (d4), K081059 (d4), K140478 (d4), K060694 (d4), K060716 (d4), K091196 (d4), K111596 (d4), K121183 (d4), K122698 (d4), K905786 (d4), K161742 (d4), K170748 (d4), K183696 (d4), K192855 (d4), K063470 (d5), K060988 (d5), K073331 (d5), K102670 (d5), K982981 (d5), K030047 (d5), K030055 (d5), K031454 (d5), K042989 (d5), K050124 (d5), K052996 (d5), K070369 (d5), K073449 (d5), K102795 (d5), K110555 (d5), K810120 (d5), K861114 (d5), K861433 (d5), K911685 (d5), K920639 (d5), K920640 (d5), K921181 (d5), K921277 (d5), K921301 (d5), K926107 (d5), K954417 (d5), K970501 (d5), K991990 (d5), K060209 (d5), K063081 (d5), K952928 (d5), K994392 (d5), K071147 (d5), K100886 (d5), K123954 (d5), K133585 (d5), K140749 (d5), K041066 (d5), K050316 (d5), K100142 (d5), K132285 (d5), K140082 (d5), K073714 (d5), K142923 (d5), K112898 (d5), K143374 (d5), K150583 (d5), K052906 (d5), K110708 (d5), K110306 (d5), K153008 (d5), K060704 (d5), K071379 (d5), K101996 (d5), K133834 (d5), K031729 (d5), K040267 (d5), K042883 (d5), K051146 (d5), K063423 (d5), K072221 (d5), K071881 (d5), K150307 (d5), K172326 (d5), K172210 (d5), K093533 (d6), K022051 (d6), K032396 (d6), K042037 (d6), K042051 (d6), K062995 (d6), K101336 (d6), K021891 (d6), K072154 (d6), K102975 (d6), K850766 (d6), K851213 (d6), K934765 (d6), K953490 (d6), K960094 (d6), K974093 (d6), K974095 (d6), K053569 (d6), K112389 (d6), K130126 (d6), K131129 (d6), K133039 (d6), K051023 (d6), K103374 (d6), K161863 (d6), K042993 (d6), K050539 (d6), K051380 (d6), K053514 (d6), K061521 (d6), K062037 (d6), K070095 (d6), K072575 (d6), K090763 (d6), K123166 (d6), K123486 (d6), K132624 (d6), K141056 (d6), K143393 (d6), K082358 (d7), K050327 (d7), K070364 (d7), K070399 (d7), K072020 (d7), K083116 (d7), K093644 (d7), K100048 (d7), K070479 (d7), K974556 (d7), K072160 (d7), K050897 (d7), K123122 (d7), K051977 (d7), K042067 (d7), K053340 (d7), K100391 (d7), K062113 (d7), K103835 (d7), K073102 (d8), K080528 (d8), K090103 (d8), K042871 (d8), K052888 (d8), K950521 (d8), K990598 (d8), K992065 (d8)

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

Manufacturer compliance record — SenTec AG

  • NAI 2016-04-28 SenTec AG · 0 citations
  • NAI 2016-04-28 SenTec AG · 0 citations
  • NAI 2012-10-25 SenTec AG · 0 citations
  • NAI 2012-10-25 SenTec AG · 0 citations