Adverse-event reports (MAUDE)
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.
Recall history
No recalls linked.
Regulatory clearances
Predicate lineage
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.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2014-11-13 | NAI | No action indicated | Well Lead Medical Co., Ltd. | 0 |
| 2014-11-13 | NAI | No action indicated | WELL LEAD MEDICAL CO. LTD | 0 |
| 2014-11-13 | NAI | No action indicated | WELL LEAD MEDICAL CO. LTD | 0 |
| 2014-11-13 | NAI | No action indicated | Well Lead Medical Co., Ltd. | 0 |
| 2011-12-15 | VAI | Voluntary action indicated | Well Lead Medical Co., Ltd. | 0 |
| 2011-12-15 | VAI | Voluntary action indicated | Well Lead Medical Co., Ltd. | 0 |
Similar devices
- 15 mm Adaptor Boston Medical Products, Inc.
- 15 mm Adaptor Boston Medical Products, Inc.
- 15 mm Adaptor Boston Medical Products, Inc.
- 15 mm Adaptor Boston Medical Products, Inc.
- 15 mm Adaptor Boston Medical Products, Inc.
- 15 mm Adaptor Boston Medical Products, Inc.
- ALM Tube inomed Medizintechnik GmbH
- ALM Tube inomed Medizintechnik GmbH
- ALM Tube inomed Medizintechnik GmbH
- ALM Tube inomed Medizintechnik GmbH
- AMSure® Endotracheal Tube AMSINO INTERNATIONAL, INC.
- AMSure® Endotracheal Tube AMSINO INTERNATIONAL, INC.
Select up to two to place side-by-side with this device.