510(k) Report

510(k) · Cleared

Cleared

Modification to Escort II+ 400 Series 9ESCORT Prism) Monitor, Models 20400, 20401, 20403, 20411, 20412, 20413, 20414

K014294510(k) SpecialCleared Jan 25, 200228-day reviewClass II21 CFR 870.2700

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

Medical Data Electronics · DQA Oximeter

Cleared on Jan 25, 2002 after a 28-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.

Decided
Jan 25, 2002
Review
28 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
0

12 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2009: 2 descendants cleared2013: 2 descendants cleared2010: 1 descendant cleared2015: 2 descendants cleared2017: 2 descendants cleared2016: 1 descendant cleared2018: 1 descendant cleared200020052010201520202025
  1. This deviceK014294 Modification to Escort II+ 400 Series 9ESCORT Prism) Monitor, Models…Medical Data Electronics · 2002
  2. Descendant · cites it directly · 11 of its ownK062144 Escort M8 Vital Signs Patient Monitor, Model 3810Invivo Corporation · 2006
  3. Descendant · 2 generations on · 10 of its ownK090556 Spacelabs Elance Vital Signs Monitoring System and Central Monitor…Spacelabs Healthcare Medical Equipment (Suzhou) CO · 2009 · Recalled
  4. Descendant · 3 generations on · 3 of its ownK130740 Nightingale Monitoring SystemZoe Medical, Inc. · 2013
  5. Descendant · 3 generations on · 2 of its ownK123556 Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2013 · Recalled
  6. Descendant · 4 generations on · 1 of its ownK161517 Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2017

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2006: 12009: 22010: 12013: 22015: 22016: 12017: 22018: 1
2006high 2 (2009) · low 0 (2007)2026

Most influential descendants

Showing 5 of 12 · See all
  • K062144Escort M8 Vital Signs Patient Monitor, Model 3810Invivo Corporation · 2006 · cites it directly11descendants
  • K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO · 2009 · 2 generations on10descendants
  • K130740Nightingale Monitoring SystemZoe Medical, Inc. · 2013 · 3 generations on3descendants
  • K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2013 · 3 generations on2descendants
  • K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2017 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K014294Modification to Escort II+ 400 Series 9ESCORT Prism) Monitor, Models 20400…Medical Data Electronics2002—
+1K062144Escort M8 Vital Signs Patient Monitor, Model 3810Invivo Corporation2006—
+2K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO20091
+3K130740Nightingale Monitoring SystemZoe Medical, Inc.2013—
+3K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc.20131
+4K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200920
201010
201320
201520
201610
201720
201810
FIG. 1 — Lineage of K014294, 2002–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 DQA? 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 DQA device

  1. #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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
*—ESCORT II+ 400 Series (ESCORT Prism) Monitor
Named without a submission number
—

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K062144Escort M8 Vital Signs Patient Monitor, Model 3810Invivo Corporation200611

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, K062144 (Invivo Corporation, 2006) has gone furthest, with 11 descendants of its own.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQA

15in 2025

2007: 202008: 222009: 352010: 292011: 152012: 142013: 152014: 112015: 132016: 142017: 92018: 182019: 192020: 152021: 102022: 202023: 132024: 142025: 152026 (partial year): 8
2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007: 122 days median2008: 97 days median2009: 117 days median2010: 127 days median2011: 195 days median2012: 120 days median2013: 182 days median2014: 175 days median2015: 158 days median2016: 246 days median2017: 200 days median2018: 260 days median2019: 158 days median2020: 126 days median2021: 174 days median2022: 265 days median2023: 317 days median2024: 285 days median2025: 182 days median2026 (partial year): 187 days median
2007high 317 (2023) · low 97 (2008)2026

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

Recalls per year · DQA

3in 2024

2007: 62008: 52009: 292010: 42011: 12014: 22015: 12018: 322024: 3
2007high 32 (2018) · low 0 (2012)2026

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

Adverse event reports per year · DQA

399in 2025

2007: 3252008: 3122009: 2812010: 1852011: 1642012: 3222013: 4682014: 1,1242015: 2,0822016: 1,7752017: 1,1902018: 6942019: 5482020: 4262021: 5532022: 4782023: 3922024: 5452025: 399
2007high 2,082 (2015) · low 164 (2011)2025

MAUDE reports naming product code DQA, 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
2007201226325
200822975312
20093511729281
2010291274185
2011151951164
2012141200322
2013151820468
20141117521,124
20151315812,082
20161424601,775
2017920001,190
20181826032694
2019191580548
2020151260426
2021101740553
2022202650478
2023133170392
2024142853545
2025151820399
202681870—

What is it indicated for?

The Medical Data Electronics ESCORT II+ 400 Series Monitor is a portable patient monitor intended to be used for monitoring vital signs of critically ill adult, pediatric and neonatal patients in the hospital environment.

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

More from Medical Data Electronics

27 FDA decisions under this applicant name. See the company

  • 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
  • K982104Escort-Link Central Station Monitor Model 20500Medical Data Electronics · 1998

Recent decisions in DQA

The DQA category page

  • K260490Ninenovo Blood Oxygen Ring…Shenzhen Ninenovo Technology Limited · 2026
  • K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH · 2026
  • K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd. · 2026
  • K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor…Philips Medizin Systeme · 2026
  • K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc. · 2026

https://510kreport.com/device/K014294 · printed Nov 4, 2026

Cite this page

510(k) Report. “K014294: Modification to Escort II+ 400 Series 9ESCORT Prism) Monitor, Models 20400, 20401, 20403, 20411, 20412, 20413, 20414.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K014294

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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