510(k) · Cleared
Cleared506 Patient Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ciriticare Systems, Inc. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Aug 12, 2005 as substantially equivalent to K022435 (Criticare Systems, Inc., 2002) after a 109-day review. Its family tree reaches back 2 generations to 1995. 4 later devices descend from it.
- Decided
- Aug 12, 2005
- Review
- 109 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944860 (1995). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK944860 Scholar Patient MonitorCriticare Systems, Inc. · 1995
- 1 generation backK022435 507EL Vital Signs MonitorCriticare Systems, Inc. · 2002
- This deviceK051038 506 Patient MonitorCiriticare Systems, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK101259 V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002Taidoc Technology Corporation · 2010
- Descendant · cites it directly · 1 of its ownK091050 506CN Patient MonitorCriticare Systems, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK172221 VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs…Taidoc Technology Corporation · 2018
- Descendant · 2 generations on · 0 of its ownK101602 Vital Signs MonitorCriticare Systems, Inc. · 2010
Most influential descendants
Showing 4 of 4 · See all- K101259V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002Taidoc Technology Corporation · 2010 · cites it directly1descendant
- K091050506CN Patient MonitorCriticare Systems, Inc. · 2009 · cites it directly1descendant
- K172221VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100Taidoc Technology Corporation · 2018 · 2 generations on0descendants
- K101602Vital Signs MonitorCriticare Systems, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944860 | Scholar Patient Monitor | Criticare Systems, Inc. | 1995 | — |
| −1 | K022435 | 507EL Vital Signs Monitor | Criticare Systems, Inc. | 2002 | — |
| 0 (this device) | K051038 | 506 Patient Monitor | Ciriticare Systems, Inc. | 2005 | — |
| +1 | K101259 | V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002 | Taidoc Technology Corporation | 2010 | — |
| +1 | K091050 | 506CN Patient Monitor | Criticare Systems, Inc. | 2009 | — |
| +2 | K172221 | VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model… | Taidoc Technology Corporation | 2018 | — |
| +2 | K101602 | Vital Signs Monitor | Criticare Systems, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2018 | 1 | 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 |
|---|---|---|---|
| * | K022435 | 507EL Vital Signs MonitorSummary page 1…Vital Signs Monitor Classification Name: Monitor, Physiological, Patient (74 MWI) Substantial Equivalence is claimed to: 507EL Vital Signs Monitoring System (K022435). Device Description: The 506 monitor measures and displays real time physiological data of the patient, including a pulse bar p… | 2002 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K101259 (Taidoc Technology Corporation, 2010) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K022435.
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 506 Patient monitor interprets and displays real time physiological data of the patient including numerical data. The 506 is configured to monitor Noninvasive BP (NIBP), SpO,, and Temperature. For each patient vital parameter, the 506 will be capable of providing limit alarms and alerts, printing of strip chart recordings and storing data trends for retrospective review. The 506 monitor utilizes existing core technologies from the predicate 507EL…
Read the full statement (173 words)
The 506 Patient monitor interprets and displays real time physiological data of the patient including numerical data. The 506 is configured to monitor Noninvasive BP (NIBP), SpO,, and Temperature. For each patient vital parameter, the 506 will be capable of providing limit alarms and alerts, printing of strip chart recordings and storing data trends for retrospective review. The 506 monitor utilizes existing core technologies from the predicate 507EL monitor for patient monitoring of NIBP, SpO,, and Temperature. Temperature measurement is provided by Kendall's Filac FasTemp module, which has been integrated into the 506 monitor. This temperature measurement technology allows predictive or continuous temperature measurement on adult or pediatric patients in oral, axillar, or rectal placements. SpO2 can optionally be provided by Nellcor's SpO2 module.
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.
https://510kreport.com/device/K051038 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051038: 506 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/K051038
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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