510(k) · Cleared
ClearedIqvitals and Iqvitals System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brentwood Medical Technology Corp. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on May 26, 2010 as substantially equivalent to K040012 (Zoe Medical, Inc., 2004) after a 55-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- May 26, 2010
- Review
- 55 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K864318 (1987). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK864318 The Buddy System/Health Information SystemThe Buddy Systems, Inc. · 1987
- 2 generations backK952979 Hanc NetworkHealthtech Services Corp. · 1996
- 1 generation backK040012 Well@Home SystemZoe Medical, Inc. · 2004 · Recalled
- This deviceK100913 Iqvitals and Iqvitals SystemBrentwood Medical Technology Corp. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864318 | The Buddy System/Health Information System | The Buddy Systems, Inc. | 1987 | — |
| −2 | K952979 | Hanc Network | Healthtech Services Corp. | 1996 | — |
| −1 | K040012 | Well@Home System | Zoe Medical, Inc. | 2004 | 1 |
| 0 (this device) | K100913 | Iqvitals and Iqvitals System | Brentwood Medical Technology Corp. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 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 DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 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 |
|---|---|---|---|
| * | K040012 | Well@Home SystemSummary page 1…are no different technologies between the lQvitals and lQvitals System and the predicate Well@Home System. The legally marketed predicate device is the Well@Home System (K040012). Intended Use The lQvitals and lQvitals System is intended to be used by clinicians and medically qualified personnel for measu… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- 2 of the 9 ancestors have a recall of any class.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
The IQvitals and lQvitals System is intended to be used by clinicians and medically qualified personnel for measuring adult and pediatric patients for noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arterial hemoglobin (SPO2), temperature and weight.
Patient information such as name, age, height, pain score etc. can be entered manually.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100913: Iqvitals and Iqvitals System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100913
Report an extraction error
Are you the manufacturer?
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