510(k) Report

510(k) · Cleared

Cleared

Esort II + 400 Series Monitor

K961138510(k) TraditionalCleared Dec 10, 1996264-day reviewClass II21 CFR 870.5550

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

Medical Data Electronics · DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

Cleared on Dec 10, 1996 after a 264-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Dec 10, 1996
Review
264 days
Class
Class II
Product code
DRO
Recalls
None
Predicates
0

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

Descendants, by year cleared 2001: 1 descendant cleared1995200020052010201520202025
  1. This deviceK961138 Esort II + 400 Series MonitorMedical Data Electronics · 1996
  2. Descendant · cites it directly · 0 of its ownK012336 Modification to:Escort Vision Central Station Telemetry System…Medical Data Electronics · 2001

Most influential descendants

Showing 1 of 1 · See all
  • K012336Modification to:Escort Vision Central Station Telemetry System, Model 20500Medical Data Electronics · 2001 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K961138Esort II + 400 Series MonitorMedical Data Electronics1996—
+1K012336Modification to:Escort Vision Central Station Telemetry System, Model 20500Medical Data Electronics2001—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
FIG. 1 — Lineage of K961138, 1996–2001Source: 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 DRO? 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?

FDA lists a 510(k) statement for it but has not posted the file, 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
K012336Modification to:Escort Vision Central Station Telemetry System, Model 20500Medical Data Electronics20010

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, K012336 (Medical Data Electronics, 2001) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DRO devices

DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRO

FDA has decided no DRO device since 2007.

Median 510(k) review, days · DRO

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

Recalls per year · DRO

12in 2020

2010: 12014: 4, 4 Class I2020: 12
2007high 12 (2020) · low 0 (2007)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · DRO

2in 2025

2007: 72008: 52009: 32010: 72011: 32012: 82013: 112014: 22015: 412016: 492017: 152018: 642019: 932020: 192021: 222023: 62024: 42025: 2
2007high 93 (2019) · low 0 (2022)2025

MAUDE reports naming product code DRO, 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—07
20080—05
20090—03
20100—17
20110—03
20120—08
20130—011
20140—4 (4)2
20150—041
20160—049
20170—015
20180—064
20190—093
20200—1219
20210—022
20220—00
20230—06
20240—04
20250—02
20260—0—

More from Medical Data Electronics

27 FDA decisions under this applicant name. See the company

  • K014294Modification to Escort II+ 400 Series 9ESCORT Prism) Monitor, Models 20400, 20401, 20403, 20411, 20412…Medical Data Electronics · 2002
  • K012336Modification to:Escort Vision Central Station Telemetry System, Model 20500Medical Data Electronics · 2001
  • K000660Escort II+ 400 Series (Escort Prism), Model 20400, 20401, 20403, Monitor, Models 20411, 20412, 20413Medical Data Electronics · 2000
  • K992413Escort 100/300 Series B (Escort II) Patient MonitorMedical Data Electronics · 1999
  • K992411Escort II+ 400 Series (Escort Prism) MonitorMedical Data Electronics · 1999

Recent decisions in DRO

The DRO category page

  • K012218Ludlow Gradient Edge Adult & Pediatric Multifunctional ElectrodesThe Ludlow Company LP · 20014 Class I recalls
  • K012404K-Defib/Pace Adult Electrode, Model KDP-85Katecho, Inc. · 2001
  • K000660Escort II+ 400 Series (Escort Prism), Model 20400, 20401, 20403, Monitor, Models 20411, 20412, 20413Medical Data Electronics · 2000
  • K983196Padtak Pace/Defib/Cardiovert Monitoring Electrode (S)Tz Medical, Inc. · 19991 recall
  • K983232Padtak Pediatric Defib/Cardiovert/Pace/Monitor-Radiotransparent (2X2.25),Model 2602, Padtak Pediatric…Tz Medical, Inc. · 1999

https://510kreport.com/device/K961138 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961138: Esort II + 400 Series Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961138

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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