510(k) Report

510(k) · Cleared

Cleared

Astronomer Plus System

K013349510(k) AbbreviatedCleared Apr 9, 2002182-day reviewClass II21 CFR 870.1425

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

Ep Technologies, Inc. · DQK Computer, Diagnostic, Programmable

Cleared on Apr 9, 2002 as substantially equivalent to K003362 (Boston Scientific Corp, 2001) and 4 other predicates after a 182-day review. Its family tree reaches back 2 generations to 1995.

Decided
Apr 9, 2002
Review
182 days
Class
Class II
Product code
DQK
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K954395 (1995). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 2 other ancestors2000: 2 other ancestorsK954395 · Carto System · Biosense, Ltd. · 1995K992968 · Carto EP Navigation System · Biosense Webster, Inc. · 199919961998200020022004
Other ancestors, by generation 1 generation back: 4 other ancestors K992968 · Carto EP Navigation System · Biosense Webster, Inc. · 1999K954395 · Carto System · Biosense, Ltd. · 19950
  1. Root · 2 generations backK954395 Carto SystemBiosense, Ltd. · 1995
  2. 1 generation backK992968 Carto EP Navigation SystemBiosense Webster, Inc. · 1999
  3. This deviceK013349 Astronomer Plus SystemEp Technologies, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K954395Carto SystemBiosense, Ltd.1995—
−1K992968Carto EP Navigation SystemBiosense Webster, Inc.1999—
0 (this device)K013349Astronomer Plus SystemEp Technologies, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020
200120
FIG. 1 — Lineage of K013349, 1995–2002Source: 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 DQK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DQK device

  1. #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 28 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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
*K003362Astronomer+with SLD
Summary page 1
…g and Tracking System; Biosense CARTO™ System; Endocardial Solutions EnSite 3000® System; Medtronic LocaLisa® Cardiac Navigation System Predicate Device Reference(s) K003362; K992912; K992968; K001437; K002869 Predicate Device Classification Name(s) Programmable Diagnostic Computer Predicate Device…
Boston Scientific Corp2001—
*K992912Cardiac Pathways Reference Catheter and Reference Catheter with Tracking, Cardiac…
Summary page 1
…cking System; Biosense CARTO™ System; Endocardial Solutions EnSite 3000® System; Medtronic LocaLisa® Cardiac Navigation System Predicate Device Reference(s) K003362; K992912; K992968; K001437; K002869 Predicate Device Classification Name(s) Programmable Diagnostic Computer Predicate Device Classifi…
Cardiac Pathways Corp.20001
*K992968Carto EP Navigation System
Summary page 1
…tem; Biosense CARTO™ System; Endocardial Solutions EnSite 3000® System; Medtronic LocaLisa® Cardiac Navigation System Predicate Device Reference(s) K003362; K992912; K992968; K001437; K002869 Predicate Device Classification Name(s) Programmable Diagnostic Computer Predicate Device Classification(s)…
Biosense Webster, Inc.1999—
*K001437Ensite 3000 System, Model EE3000
Summary page 1
…ense CARTO™ System; Endocardial Solutions EnSite 3000® System; Medtronic LocaLisa® Cardiac Navigation System Predicate Device Reference(s) K003362; K992912; K992968; K001437; K002869 Predicate Device Classification Name(s) Programmable Diagnostic Computer Predicate Device Classification(s) Class I…
Endocardial Solutions, Inc.2000—
*K002869Localisa Cardiac Navigation System
Summary page 1
…O™ System; Endocardial Solutions EnSite 3000® System; Medtronic LocaLisa® Cardiac Navigation System Predicate Device Reference(s) K003362; K992912; K992968; K001437; K002869 Predicate Device Classification Name(s) Programmable Diagnostic Computer Predicate Device Classification(s) Class I DQK 21 C…
Medtronic Surgical Navigation Technologies2001—

Also cleared against K003362: 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?

  • The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • 1 other device also cites its predicate K003362.

How does its category compare?

All DQK devices

DQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQK

23so far in 2026, the most since 2007

2007: 132008: 42009: 122010: 92011: 122012: 72013: 132014: 92015: 72016: 152017: 72018: 142019: 152020: 162021: 162022: 192023: 212024: 132025: 222026 (partial year): 23
2007high 23 (2026) · low 4 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQK

95in 2025

2007: 83 days median2008: 70 days median2009: 93 days median2010: 64 days median2011: 69 days median2012: 74 days median2013: 68 days median2014: 90 days median2015: 125 days median2016: 190 days median2017: 146 days median2018: 150 days median2019: 113 days median2020: 123 days median2021: 132 days median2022: 136 days median2023: 133 days median2024: 100 days median2025: 95 days median2026 (partial year): 151 days median
2007high 190 (2016) · low 64 (2010)2026

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

Recalls per year · DQK

1in 2025

2007: 42008: 12009: 22010: 32011: 22012: 32013: 12014: 42015: 22017: 22018: 62019: 12020: 12021: 12022: 22023: 22024: 242025: 12026 (partial year): 2
2007high 24 (2024) · low 0 (2016)2026

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

Adverse event reports per year · DQK

433in 2025

2007: 182008: 342009: 402010: 492011: 552012: 1292013: 1802014: 1152015: 1312016: 3402017: 2522018: 2612019: 2182020: 2152021: 3512022: 3192023: 3402024: 5572025: 433
2007high 557 (2024) · low 18 (2007)2025

MAUDE reports naming product code DQK, 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
20071383418
2008470134
20091293240
2010964349
20111269255
20127743129
201313681180
20149904115
201571252131
2016151900340
201771462252
2018141506261
2019151131218
2020161231215
2021161321351
2022191362319
2023211332340
20241310024557
202522951433
2026231512—

What is it indicated for?

The Astronomer Plus™ System is a computerized system to assist in the diagnosis of complex cardiac arrhythmias. The Astronomer Plus™ System can be used to:

+ Display the relative location of catheters during cardiac mapping procedures (used exclusively with the Constellation® Catheter);

* Route externally generated pacing stimuli and transmit cardiac electrogram (EGM) signals to electrophysiology recorders; and

* Document electrophysiological procedures which make use of the Constellation® Catheter.

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 K003362

1 other device cites the same predicate.

  • K110878Rhythmview (TM)Topera, Inc. · 2011

More from Ep Technologies, Inc.

15 FDA decisions under this applicant name. See the company

  • K043257Real-Time Position Management (RPM) SystemEp Technologies, Inc. · 2005
  • K003452Polaris X Catheters, Model 7000D,7001D,7003D,7004D,7005D,7006DEp Technologies, Inc. · 2000
  • K940167Diagnostic I CatheterEp Technologies, Inc. · 1994
  • K940168Diagnostic II CatheterEp Technologies, Inc. · 1994
  • K924108Tracfinder IIEp Technologies, Inc. · 1993

Recent decisions in DQK

The DQK category page

  • K263380STAR Apollo™ Mapping SystemRhythm AI, Ltd. · 2026
  • K263016Intra-Operative Positioning System (IOPS) and IOPS Visionary SystemCenterline Biomedical · 2026
  • K261729EnSite™ X EP SystemAbbott Medical · 2026
  • K253692AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific · 2026
  • K262005Affera Integrated Mapping SystemMedtronic, Inc. · 2026

https://510kreport.com/device/K013349 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013349: Astronomer Plus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013349

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026