# K972001: Nicas (TM) Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Ni Medical
- Decided: Jul 8, 1997 after 39 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
Longest line of descent: 1 generation back to K954504 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942227: Nicas 2001 Noninvasive Cardio-Respiratory System, C.L. Mcintosh & Assoc., Inc. (1996) Summary page 1.
- K954504: K-Defib/Pace Pediatric Electrode, Katecho, Inc. (1995). Our OCR of the scanned summary read K954505, FDA’s number for EZ Stim (Life-Tech Intl., Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Katecho, Inc. K-Defib/Pace Pediatric Electrode”.

## Indications for use
The NICaS™ electrode is used only in conjunction with the NICasS™ 2001 and all other NICas™ devices. The function of the NICasS™ electrode :s unchanged from that of the Nicolet Biomedical Instruments Velcro ground strap in the original NICas™ 2001 cardio-respiratory system, (510(k)K942227) submission, namely, to transmit electrical signals to and from the skin and the NICas™ 2001 cardio-respiratory system. The indications for use of the NICaS™ 2001 cardio-respiratory system remain unchanged from those included in the original NICaS™ 2001 cardio-respiratory system, (510(k) K942227), namely, monitoring hemodynamic parameters including stroke volume, stroke index. heart rate, cardiac index, cardiac output, and total peripheral resistance; and the ventilatory parameter, respiratory rate. The device is intended for use in male and female patients with cardiovascular disorders including: ] patients undergoing cardiac catheterization . cardiac surgery patients . patients in intensive and cardiac care units ] patients in rehabilitation centers

Source page: https://510kreport.com/device/K972001
Methodology: https://510kreport.com/methodology