510(k) Report

510(k) · Cleared

Cleared

Nicas (TM) Electrode

K972001510(k) TraditionalCleared Jul 8, 199739-day reviewClass II21 CFR 870.2360

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ni Medical · DRX Electrode, Electrocardiograph

Cleared on Jul 8, 1997 as substantially equivalent to K942227 (C.L. Mcintosh & Assoc., Inc., 1996) and 1 other predicate after a 39-day review. Its family tree reaches back 1 generation to 1995.

Decided
Jul 8, 1997
Review
39 days
Class
Class II
Product code
DRX
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K954504 (1995). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestorK954504 · K-Defib/Pace Pediatric Electrode · Katecho, Inc. · 199519961998
Other ancestors, by generation 1 generation back: 1 other ancestor K954504 · K-Defib/Pace Pediatric Electrode · Katecho, Inc. · 19950
  1. Root · 1 generation backK954504 K-Defib/Pace Pediatric ElectrodeKatecho, Inc. · 1995
  2. This deviceK972001 Nicas (TM) ElectrodeNi Medical · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K954504K-Defib/Pace Pediatric ElectrodeKatecho, Inc.1995—
0 (this device)K972001Nicas (TM) ElectrodeNi Medical1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K972001, 1995–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K942227Nicas 2001 Noninvasive Cardio-Respiratory System
Summary page 1
…ment Classification Name: Predicate Devices: With respect to indication for use: Nicolet Biomedical Instruments Velcro ground strap included in the NICaS™ 2001 510(k), (K942227) With respect to materials and biocompatability: Katecho, Inc. K-Defib/Pace Pediatric Electrode (K954505) Device Description:…
C.L. Mcintosh & Assoc., Inc.1996—
*K954504K-Defib/Pace Pediatric Electrode
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”.
Katecho, Inc.1995—

Also cleared against K942227: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 2 ancestors has a recall.
  • 1 other device also cites its predicate K942227.

How does its category compare?

All DRX devices

DRX Electrode, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRX

1in 2017

2007: 32008: 32009: 72010: 52013: 12014: 12017: 1
2007high 7 (2009) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRX

78in 2010

2007: 147 days median2008: 17 days median2009: 89 days median2010: 78 days median
2007high 147 (2007) · low 17 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DRX

6in 2022

2010: 42015: 12020: 52021: 12022: 6
2007high 6 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DRX

250in 2025

2007: 472008: 152009: 362010: 482011: 802012: 412013: 702014: 272015: 582016: 372017: 552018: 432019: 502020: 532021: 552022: 612023: 1132024: 612025: 250
2007high 250 (2025) · low 15 (2008)2025

MAUDE reports naming product code DRX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073147047
2008317015
2009789036
2010578448
20110—080
20120—041
20131—070
20141—027
20150—158
20160—037
20171—055
20180—043
20190—050
20200—553
20210—155
20220—661
20230—0113
20240—061
20250—0250
20260—0—

What is it indicated for?

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…

Read the full statement (146 words)

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

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K942227

1 other device cites the same predicate.

  • K070500Bioimpedance Cardiac Analyzing Measuring System, Model Nicas 2004 SlimNi Medical · 2007

More from Ni Medical

2 FDA decisions under this applicant name. See the company

  • K070500Bioimpedance Cardiac Analyzing Measuring System, Model Nicas 2004 SlimNi Medical · 2007

Recent decisions in DRX

The DRX category page

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  • K101685IP-SETIntegral Process Sas · 20106 recalls

https://510kreport.com/device/K972001 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972001: Nicas (TM) Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972001

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026