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 |
|---|---|---|---|---|
| 2023-12-14 | NAI | No action indicated | APK Technology Co., Ltd. | 0 |
| 2023-12-14 | NAI | No action indicated | APK Technology Co., Ltd. | 0 |
| 2019-10-24 | VAI | Voluntary action indicated | APK Technology Co., Ltd. | 0 |
| 2019-10-24 | VAI | Voluntary action indicated | APK Technology Co., Ltd. | 0 |
| 2016-04-14 | VAI | Voluntary action indicated | APK Technology Co., Ltd. | 3 |
| 2016-04-14 | VAI | Voluntary action indicated | APK Technology Co., Ltd. | 3 |
| 2015-08-06 | WL | Warning Letter | APK Technology Co., Ltd. | — |
| 2015-08-06 | WL | Warning Letter | APK Technology Co., Ltd. | — |
| 2015-02-03 | OAI | Official action indicated | APK Technology Co., Ltd. | 0 |
| 2015-02-03 | OAI | Official action indicated | APK Technology Co., Ltd. | 0 |
Similar devices
- ECG cable Edan Instruments, Inc.
- ECG limb cable Edan Instruments, Inc.
- ECG limb wires Edan Instruments, Inc.
- ECG limb wires Edan Instruments, Inc.
- Interm Cbl Trident (NMT), 1.9m DRAEGER MEDICAL SYSTEMS, INC.
- """SELL19893"" LW PLP2000,3LEAD,SNAP,29""AHA" CURBELL MEDICAL PRODUCTS, INC.
- """SELL19896"" LW PLP2000,3LEAD,PNCH,29""AHA" CURBELL MEDICAL PRODUCTS, INC.
- "3-LD SET, PINCH TO DIN, A, 24""" CURBELL MEDICAL PRODUCTS, INC.
- "3-LD SET,PINCH TO DIN,A,24"",INTERMED" CURBELL MEDICAL PRODUCTS, INC.
- "3-LD Set, SNAP - DIN, UNSHIELDED, A,120""" CURBELL MEDICAL PRODUCTS, INC.
- "3-LD Set, SNAP to DIN, UNSHIELDED, A,24""" CURBELL MEDICAL PRODUCTS, INC.
- "3-LD Set, SNAP to DIN, UNSHIELDED, A,40""" CURBELL MEDICAL PRODUCTS, INC.
Select up to two to place side-by-side with this device.