# K990027: Omnicorder, Model 464

- Pathway: 510(k) (Abbreviated)
- Applicant: Del Mar Avionics
- Decided: Feb 9, 1999 after 35 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2800
- 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 K950020 (1995). 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)
- K950020: Holter Pacercorder (R), Del Mar Avionics (1995) Summary page 1.

## Indications for use
The Del Mar Avionics Model 464 DigiCorder™ is a 3-channel ECG analog cassette tape recorder. By an operator settable dip switches the recorder will perform either conventional 3-channel ECG recording or pacemaker detection recording 2 channels of ECG and 1 channel of “pseudo” pacemaker pulses each time the patient’s implanted pacemaker produces a detectable pulse. A second operator selectable dip switch allows selection of recording speed at 0.5 mm/S, 1.0 mm/S or 1.5 mm/S. The Del Mar Avionics Model 464 OmniCorder™ is intended for use as a Holter ECG cardiac-monitoring tool.

Source page: https://510kreport.com/device/K990027
Methodology: https://510kreport.com/methodology