510(k) Report

510(k) · Cleared

Cleared

Cygnus 12 Lead Ecg Module

K072950510(k) TraditionalCleared Aug 22, 2008309-day reviewClass II21 CFR 870.3640

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

Cygnus, LLC · KRE Analyzer, Pacemaker Generator Function, Indirect

Cleared on Aug 22, 2008 as substantially equivalent to K915632 (Paceart, Inc., 1992) after a 309-day review. Its family tree reaches back 1 generation to 1992.

Decided
Aug 22, 2008
Review
309 days
Class
Class II
Product code
KRE
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K915632 (1992). No later device cites it as a predicate yet.

K915632 · Paceart CPTS-86/12 · Paceart, Inc. · 199219901995200020052010
K915632 · Paceart CPTS-86/12 · Paceart, Inc. · 19920
  1. Root · 1 generation backK915632 Paceart CPTS-86/12Paceart, Inc. · 1992
  2. This deviceK072950 Cygnus 12 Lead Ecg ModuleCygnus, LLC · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K915632Paceart CPTS-86/12Paceart, Inc.1992—
0 (this device)K072950Cygnus 12 Lead Ecg ModuleCygnus, LLC2008—
FIG. 1 — Lineage of K072950, 1992–2008Source: 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 KRE? 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
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What was it cleared against? (1)

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
*K915632Paceart CPTS-86/12
Summary page 2
…only. It is not intended to be used with wireless networks. 5. Substantially equivalent devices: Cygnus LLC considers the legally marketed PACEART CPTS-86/12 (K915632) cardiac receiving station to be substantially equivalent to Cygnus 12 Lead/TTM ECG Module, with a number of features shared. 6.…
Paceart, Inc.1992—

Also cleared against K915632: 3 other devices →

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?

  • Its one ancestor has no recall.
  • 3 other devices also cite its predicate K915632.

How does its category compare?

All KRE devices

KRE Analyzer, Pacemaker Generator Function, Indirect: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · KRE

1in 2011

2008: 12011: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRE

Too few KRE 510(k)s in any year since 2007 to give a median.

Recalls per year · KRE

No recall names KRE since 2007.

Adverse event reports per year · KRE

2in 2023

2014: 22015: 12016: 72017: 12018: 62019: 32020: 42021: 142022: 22023: 2
2007high 14 (2021) · low 0 (2007)2025

MAUDE reports naming product code KRE, 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
20070—00
20081—00
20090—00
20100—00
20111—00
20120—00
20130—00
20140—02
20150—01
20160—07
20170—01
20180—06
20190—03
20200—04
20210—014
20220—02
20230—02
20240—00
20250—00
20260—0—

What is it indicated for?

The device is for prescription use only.

The device is intended to be used in a clinic or hospital.

The device is intended for use by the physician (or his/her representative), not by the patient, although one intended use is to record the patient's 12-lead ECG.

The device is intended for use as a:

Fully functional ECG/heart rate monitoring system for clinical use.

Pacemaker Detection and measurement.

A TTM (trans-telephonic) Receiving Station.

In TTM mode, the device is intended for use with landline analog and digital PBX telephone systems only. It is not intended to be used with wireless networks.

Indications for use as stated in the FDA summary.

Also cleared against K915632

3 other devices cite the same predicate.

  • K020534Medstar System, Models 533-300Cybernet Medical · 20034 recalls
  • K982384MercatorHarley Street Software, Ltd. · 1999
  • K982090Paceart Home Trak Plus Easi Event Recorder SystemPaceart, Inc. · 1999

Recent decisions in KRE

The KRE category page

  • K110693Paceart Optima System SoftwareMedtronic, Inc. · 2011
  • K032926Ekg SpeaksMedtronic Vascular · 2003
  • K922742HPM 40 Heart Pacemaker MonitorBiotronik, GmbH & Co. · 1993
  • K915632Paceart CPTS-86/12Paceart, Inc. · 1992
  • K895535PaceviewMicromedical · 1990

https://510kreport.com/device/K072950 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072950: Cygnus 12 Lead Ecg Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072950

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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