510(k) · Cleared
ClearedEscort 100/300 Series B (Escort II) Patient Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Data Electronics · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Aug 19, 1999 after a 30-day review. The FDA summary names its predicate without a number. 27 later devices descend from it.
- Decided
- Aug 19, 1999
- Review
- 30 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 1 citing it directly.
- This deviceK992413 Escort 100/300 Series B (Escort II) Patient MonitorMedical Data Electronics · 1999
- Descendant · cites it directly · 26 of its ownK052446 LG1 Intelligent Medical Vigilance SystemHoana Medical, Inc. · 2006
- Descendant · 2 generations on · 21 of its ownK082626 PAM 3000Wireless 2000 RF & Uwb Technologies, Ltd. · 2009
- Descendant · 3 generations on · 10 of its ownK092062 Everon 1.0Earlysense, Ltd. · 2010
- Descendant · 3 generations on · 9 of its ownK202464 Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc. · 2021
- Descendant · 4 generations on · 9 of its ownK120465 Earlysense (Everon) SystemEarlysense, Ltd. · 2012
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K052446LG1 Intelligent Medical Vigilance SystemHoana Medical, Inc. · 2006 · cites it directly26descendants
- K082626PAM 3000Wireless 2000 RF & Uwb Technologies, Ltd. · 2009 · 2 generations on21descendants
- K092062Everon 1.0Earlysense, Ltd. · 2010 · 3 generations on10descendants
- K202464Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc. · 2021 · 3 generations on9descendants
- K120465Earlysense (Everon) SystemEarlysense, Ltd. · 2012 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992413 | Escort 100/300 Series B (Escort II) Patient Monitor | Medical Data Electronics | 1999 | — |
| +1 | K052446 | LG1 Intelligent Medical Vigilance System | Hoana Medical, Inc. | 2006 | — |
| +2 | K082626 | PAM 3000 | Wireless 2000 RF & Uwb Technologies, Ltd. | 2009 | — |
| +3 | K092062 | Everon 1.0 | Earlysense, Ltd. | 2010 | — |
| +3 | K202464 | Vital Sign Monitoring Sensor (Model :XK300) | Xandar Kardian, Inc. | 2021 | — |
| +4 | K120465 | Earlysense (Everon) System | Earlysense, Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 5 | 0 |
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 DRT? 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 DRT device
- #1 K252676 The Circadia C300 System (C300)score 15.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | ESCORT® 100/300 Series B (ESCORT II) Patient Monitor (incorporating Nellcor technology) Named without a submission number |
What descends from it? (27)
See all 271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052446 | LG1 Intelligent Medical Vigilance System | 2006 | 26 |
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, K052446 (Hoana Medical, Inc., 2006) has gone furthest, with 26 descendants of its own.
How does its category compare?
All DRT devicesDRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRT
228in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRT
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRT
40in 2025
MAUDE reports naming product code DRT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 113 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 6 | 70 | 0 | 118 |
| 2010 | 3 | 44 | 0 | 63 |
| 2011 | 3 | 149 | 1 | 36 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 48 |
| 2016 | 1 | — | 0 | 55 |
| 2017 | 1 | — | 0 | 159 |
| 2018 | 1 | — | 0 | 224 |
| 2019 | 1 | — | 0 | 447 |
| 2020 | 0 | — | 0 | 50 |
| 2021 | 2 | — | 1 | 85 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 0 | 47 |
| 2024 | 3 | 228 | 1 | 29 |
| 2025 | 1 | — | 0 | 40 |
| 2026 | 5 | 120 | 0 | — |
What is it indicated for?
The Medical Data Electronics ESCORT 100/300 Series B Patient 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.
https://510kreport.com/device/K992413 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992413: Escort 100/300 Series B (Escort II) Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992413
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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