ORIDION CO2(Package/no accessory)
Model 115-046928-00 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · DI 06944904096759
CCJ — Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase · Class II · 21 CFR 868.1430
UDILibrary device dossier · generated 2026-09-15 · 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.
No dated reports to chart.
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K170876 — cites (transitively): K152902 (d1), K161531 (d1), K101521 (d2), K143195 (d2), K150352 (d2), K150632 (d2), K150310 (d2), K150975 (d2), K151681 (d2), K003621 (d3), K030738 (d3), K073376 (d3), K092449 (d3), K123074 (d3), K132026 (d3), K132037 (d3), K132075 (d3), K020550 (d3), K062098 (d3), K070791 (d3), K072235 (d3), K091834 (d3), K132036 (d3), K132038 (d3), K132662 (d3), K142601 (d3), K021788 (d3), K030038 (d3), K031481 (d3), K032858 (d3), K040304 (d3), K041235 (d3), K042845 (d3), K050141 (d3), K050762 (d3), K051106 (d3), K052801 (d3), K053522 (d3), K060221 (d3), K060541 (d3), K061052 (d3), K061610 (d3), K062283 (d3), K062392 (d3), K063315 (d3), K063725 (d3), K071426 (d3), K072020 (d3), K081793 (d3), K082633 (d3), K083517 (d3), K091927 (d3), K093268 (d3), K100939 (d3), K101449 (d3), K102562 (d3), K110474 (d3), K110622 (d3), K113441 (d3), K113657 (d3), K120366 (d3), K120657 (d3), K122439 (d3), K130849 (d3), K131872 (d3), K141015 (d3), K021778 (d4), K033444 (d4), K033513 (d4), K040357 (d4), K171426 (d4), K172020 (d4), K013199 (d4), K093260 (d4), K033296 (d4), K080238 (d4), K092838 (d4), K101896 (d4), K052961 (d4), K082583 (d4), K080192 (d4), K091786 (d4), K031760 (d4), K051212 (d5), K131861 (d5), K141077 (d5), K081888 (d5), K101923 (d5), P960025 (d5), K081917 (d6), K090993 (d6) — cited as predicate by K171292, K171311, K183238, K190011, K191106
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- NAI 2017-04-14 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 0 citations
- VAI 2017-04-14 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. · 0 citations
- VAI 2017-04-14 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. · 0 citations
- NAI 2017-04-14 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 0 citations
- VAI 2015-05-15 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 1 citations
- VAI 2012-04-12 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 5 citations