# K875015: Tracets 3000

- Pathway: 510(k) (Traditional)
- Applicant: Lectec Corp.
- Decided: Jan 28, 1988 after 55 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
129 later devices descend from it; 1 cites it directly.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K952979: Hanc Network (1996), 128 descendants of its own
- K964408: Poseidon Cardiac Monitoring System (PCMS) (1997), 123 descendants of its own
- K993169: Modification of: Physiological Signal Transmitter and Receiver, Model 3810A (1999), 103 descendants of its own
- K023749: The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) (2002), 98 descendants of its own
- K031840: Carematix Wellness System (2003), 90 descendants of its own

Source page: https://510kreport.com/device/K875015
Methodology: https://510kreport.com/methodology