Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
No recalls linked.
Predicate lineage
Cited as predicate by: K182667, K190011, K191769, K192514, K192584, K192972, K211475, K232962, K251160
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2017-04-14 | NAI | No action indicated | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 0 |
| 2017-04-14 | VAI | Voluntary action indicated | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | 0 |
| 2017-04-14 | VAI | Voluntary action indicated | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | 0 |
| 2017-04-14 | NAI | No action indicated | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 0 |
| 2015-05-15 | VAI | Voluntary action indicated | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 1 |
| 2012-04-12 | VAI | Voluntary action indicated | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 5 |
- Oxygen Nasal Cannula Child,W/co2 Sampling line(Male Luer) BESMED HEALTH BUSINESS CORP.
- GAS SAMPLING LINE-2.0M (FEMALE/FEMALE) BESMED HEALTH BUSINESS CORP.
- Oxygen Nasal Cannula Adult,W/co2 Sampling line(Female LUER) BESMED HEALTH BUSINESS CORP.
- Oxygen Nasal Cannula Child,W/co2 Sampling line(Female LUER) BESMED HEALTH BUSINESS CORP.
- Oxygen Nasal Cannula Child,W/co2 Sampling line(Male Luer),Universal O2 Connecto BESMED HEALTH BUSINESS CORP.
- Oxygen Nasal Cannula Infant,W/co2 Sampling line(Male Luer) BESMED HEALTH BUSINESS CORP.
- Oxygen Nasal Cannula Infant,W/co2 Sampling line(Male Luer),Universal O2 Connect BESMED HEALTH BUSINESS CORP.
- "Resp-O2 EtCO2 Nasal Sampling Cannula, 14"" (4.2 m ) O2 and CO2 Tubing " Dynarex Corporation
- ADVANCED PATIENT MONITOR ADVANCED INSTRUMENTATIONS, INC.
- ADVANCED PATIENT MONITOR ADVANCED INSTRUMENTATIONS, INC.
- ADVANCED PATIENT MONITOR ADVANCED INSTRUMENTATIONS, INC.
- ADVANCED PATIENT MONITOR ADVANCED INSTRUMENTATIONS, INC.