# K093657: Adagio Retracting Ecg Lead Wires

- Pathway: 510(k) (Traditional)
- Applicant: Acist Medical Systems, Inc.
- Decided: Jan 15, 2010 after 51 days
- Product code: DSA (Cable, Transducer And Electrode, Patient, (Including Connector))
- Device class: 2
- Regulation: 21 CFR 870.2900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K942321 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942321: Variouspatient Monitoring Cable, Merit Cables Incorporated (1994) Summary page 2.

## Indications for use
The AdagijoTm Retractable ECG patient lead wires are used to connect electrodes and/or sensors placed at the appropriate sites on the patient to a monitoring device for general monitoring and/or diagnostic evaluation by a health care professional. CAUTION: Federal (USA) law restricts sale of the Adagio'Tm ECG Leads to or on the order of a physician.

Source page: https://510kreport.com/device/K093657
Methodology: https://510kreport.com/methodology