510(k) Report

510(k) · Cleared

Cleared

Arzco Octapolar Esophageal Cardiac Record Cath

K905831510(k) TraditionalCleared Mar 29, 199188-day reviewClass II21 CFR 870.1220

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

Arzco Medical Electronics, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

Cleared on Mar 29, 1991 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Mar 29, 1991
Review
88 days
Class
Class II
Product code
DRF
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared1990200020102020
  1. This deviceK905831 Arzco Octapolar Esophageal Cardiac Record CathArzco Medical Electronics, Inc. · 1991
  2. Descendant · cites it directly · 0 of its ownK062793 Servo-I Ventilator System, Model 64 87 800 E407E; Nava OptionMaquet Critical Care AB · 2007

Most influential descendants

Showing 1 of 1 · See all
  • K062793Servo-I Ventilator System, Model 64 87 800 E407E; Nava OptionMaquet Critical Care AB · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K905831Arzco Octapolar Esophageal Cardiac Record CathArzco Medical Electronics, Inc.1991—
+1K062793Servo-I Ventilator System, Model 64 87 800 E407E; Nava OptionMaquet Critical Care AB2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of K905831, 1991–2007Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DRF? 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 DRF device

  1. #1 K252794 Vision-MR™ Diagnostic Catheterscore 13.7 · 1 generation · 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K062793Servo-I Ventilator System, Model 64 87 800 E407E; Nava OptionMaquet Critical Care AB20070

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?

  • Of its descendants, K062793 (Maquet Critical Care AB, 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DRF devices

DRF Catheter, Electrode Recording, Or Probe, Electrode Recording: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRF

3in 2025

2007: 22008: 22009: 72010: 52011: 32012: 12013: 22014: 12015: 32016: 82017: 72018: 12019: 102020: 42021: 122022: 82023: 52024: 42025: 32026 (partial year): 2
2007high 12 (2021) · low 1 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRF

45in 2023

2009: 243 days median2010: 65 days median2011: 190 days median2015: 29 days median2016: 175 days median2019: 163 days median2021: 124 days median2022: 283 days median2023: 45 days median
2007high 283 (2022) · low 29 (2015)2026

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

Recalls per year · DRF

1in 2015

2007: 22008: 42011: 62014: 22015: 1
2007high 6 (2011) · low 0 (2009)2026

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

Adverse event reports per year · DRF

508in 2025

2007: 1202008: 1762009: 1222010: 1302011: 2452012: 4022013: 3102014: 3492015: 3272016: 3832017: 4582018: 7232019: 6692020: 6512021: 6252022: 6132023: 6852024: 6232025: 508
2007high 723 (2018) · low 120 (2007)2025

MAUDE reports naming product code DRF, 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
20072—2120
20082—4176
200972430122
20105650130
201131906245
20121—0402
20132—0310
20141—2349
20153291327
201681750383
20177—0458
20181—0723
2019101630669
20204—0651
2021121240625
202282830613
20235450685
20244—0623
20253—0508
20262—0—

More from Arzco Medical Electronics, Inc.

3 FDA decisions under this applicant name. See the company

  • K904943Tapscope Esophageal Cardiac Recording StethoscopeArzco Medical Electronics, Inc. · 1991
  • K903136Arzo Tapcath Esophageal Recording CatheterArzco Medical Electronics, Inc. · 1991

Recent decisions in DRF

The DRF category page

  • K262068Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG)CathRx, Ltd. · 2026
  • K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc. · 2026
  • K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc. · 2025
  • K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific Corporation · 2025
  • P990025/S074NAVISTAR Electrophysiology CatheterBiosense Webster, Inc. · 2025

https://510kreport.com/device/K905831 · printed Nov 4, 2026

Cite this page

510(k) Report. “K905831: Arzco Octapolar Esophageal Cardiac Record Cath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K905831

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026