510(k) Report

510(k) · Cleared

Cleared

507EL Vital Signs Monitor

K022435510(k) SpecialCleared Aug 14, 200220-day reviewClass II21 CFR 870.2300

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

Criticare Systems, Inc. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Cleared on Aug 14, 2002 as substantially equivalent to K944860 (Criticare Systems, Inc., 1995) after a 20-day review. Its family tree reaches back 1 generation to 1995. 6 later devices descend from it.

Decided
Aug 14, 2002
Review
20 days
Class
Class II
Product code
DRT
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K944860 (1995). 6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2005: 1 descendant cleared2010: 2 descendants cleared2009: 1 descendant cleared2018: 1 descendant clearedK944860 · Scholar Patient Monitor · Criticare Systems, Inc. · 19951995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants K944860 · Scholar Patient Monitor · Criticare Systems, Inc. · 19950
  1. Root · 1 generation backK944860 Scholar Patient MonitorCriticare Systems, Inc. · 1995
  2. This deviceK022435 507EL Vital Signs MonitorCriticare Systems, Inc. · 2002
  3. Descendant · cites it directly · 4 of its ownK051038 506 Patient MonitorCiriticare Systems, Inc. · 2005
  4. Descendant · 2 generations on · 1 of its ownK101259 V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002Taidoc Technology Corporation · 2010
  5. Descendant · 2 generations on · 1 of its ownK091050 506CN Patient MonitorCriticare Systems, Inc. · 2009
  6. Descendant · 3 generations on · 0 of its ownK172221 VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs…Taidoc Technology Corporation · 2018
  7. Descendant · 3 generations on · 0 of its ownK101602 Vital Signs MonitorCriticare Systems, Inc. · 2010

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2003: 12005: 12009: 12010: 22018: 1
2003high 2 (2010) · low 0 (2004)2026

Most influential descendants

Showing 5 of 6 · See all
  • K051038506 Patient MonitorCiriticare Systems, Inc. · 2005 · cites it directly4descendants
  • K101259V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002Taidoc Technology Corporation · 2010 · 2 generations on1descendant
  • K091050506CN Patient MonitorCriticare Systems, Inc. · 2009 · 2 generations on1descendant
  • K172221VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100Taidoc Technology Corporation · 2018 · 3 generations on0descendants
  • K101602Vital Signs MonitorCriticare Systems, Inc. · 2010 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K944860Scholar Patient MonitorCriticare Systems, Inc.1995—
0 (this device)K022435507EL Vital Signs MonitorCriticare Systems, Inc.2002—
+1K051038506 Patient MonitorCiriticare Systems, Inc.2005—
+2K101259V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002Taidoc Technology Corporation2010—
+2K091050506CN Patient MonitorCriticare Systems, Inc.2009—
+3K172221VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model…Taidoc Technology Corporation2018—
+3K101602Vital Signs MonitorCriticare Systems, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200910
201020
201810
FIG. 1 — Lineage of K022435, 1995–2018Source: 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 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. #1 K252676 The Circadia C300 System (C300)score 15.3 · 6 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
*K944860Scholar Patient Monitor
Summary page 1
…Classification Name: Monitor, Physiological, Patient (74 MWI) Substantial Equivalence is claimed to : CSI Model 2200 Scholar Vital Signs Monitor (K944860) Device Description: The 507EL monitor measures and displays real time physiological data of the patient, including…
Criticare Systems, Inc.1995—

Also cleared against K944860: 1 other device →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K051038506 Patient MonitorCiriticare Systems, Inc.20054
K030656Envan Heart Rate MonitorEnvan, LLC20030

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?

  • Its one ancestor has no recall.
  • Of its descendants, K051038 (Ciriticare Systems, Inc., 2005) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K944860.

How does its category compare?

All DRT devices

DRT 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

2007: 12008: 12009: 62010: 32011: 32012: 12013: 12015: 12016: 12017: 12018: 12019: 12021: 22022: 12023: 12024: 32025: 12026 (partial year): 5
2007high 6 (2009) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRT

228in 2024

2009: 70 days median2010: 44 days median2011: 149 days median2024: 228 days median2026 (partial year): 120 days median
2007high 228 (2024) · low 44 (2010)2026

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

Recalls per year · DRT

1in 2024

2011: 12021: 12024: 1
2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · DRT

40in 2025

2007: 1132008: 992009: 1182010: 632011: 362012: 472013: 162014: 262015: 482016: 552017: 1592018: 2242019: 4472020: 502021: 852022: 352023: 472024: 292025: 40
2007high 447 (2019) · low 16 (2013)2025

MAUDE reports naming product code DRT, 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
20071—0113
20081—099
20096700118
2010344063
20113149136
20121—047
20131—016
20140—026
20151—048
20161—055
20171—0159
20181—0224
20191—0447
20200—050
20212—185
20221—035
20231—047
20243228129
20251—040
202651200—

What is it indicated for?

This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor.

Indications for use as stated in the FDA summary.

Also cleared against K944860

1 other device cites the same predicate.

  • K0120598100/8500 Vital Signs MonitorCriticare Systems, Inc. · 2001

More from Criticare Systems, Inc.

22 FDA decisions under this applicant name. See the company

  • K101602Vital Signs MonitorCriticare Systems, Inc. · 2010
  • K091050506CN Patient MonitorCriticare Systems, Inc. · 2009
  • K0425698600 Vital Signs MonitorCriticare Systems, Inc. · 20043 recalls
  • K030613Vital Signs Monitor W/Arrhythmia Detection and ST Analysis, Model 8100Criticare Systems, Inc. · 20031 recall
  • K0120598100/8500 Vital Signs MonitorCriticare Systems, Inc. · 2001

Recent decisions in DRT

The DRT category page

  • K262447The Circadia CX00 System (CX00)Circadia Health, Inc. · 2026
  • K254058DistaSense (TM) (v1)Life Detection Technologies · 2026
  • K261286The Circadia C300 System (C300)Circadia Health, Inc. · 2026
  • K252676The Circadia C300 System (C300)Circadia Health, Inc. · 2026
  • K253388Sleepiz One+ (Model 2.5)Sleepiz AG · 2026

https://510kreport.com/device/K022435 · printed Nov 5, 2026

Cite this page

510(k) Report. “K022435: 507EL Vital Signs Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022435

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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