510(k) · Cleared
ClearedCvinsight
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelomed, Inc. · DQA Oximeter
Cleared on Sep 4, 2012 as substantially equivalent to K102350 (Nonin Medical, Inc., 2010) and 3 other predicates after a 242-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- Sep 4, 2012
- Review
- 242 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K910772 (1991). 24 ancestors in all, the oldest K853124 (1985). No later device cites it as a predicate yet.
- Root · 7 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 6 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 5 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 4 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 3 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 2 generations backK031487 Model Avant 2120 Pulse Oximeter and NibpNonin Medical, Inc. · 2004
- 1 generation backK040589 Modification to Avant 9600 Pulse OximeterNonin Medical, Inc. · 2004
- This deviceK120052 CvinsightIntelomed, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −6 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −5 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −4 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −3 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −2 | K031487 | Model Avant 2120 Pulse Oximeter and Nibp | Nonin Medical, Inc. | 2004 | — |
| −1 | K040589 | Modification to Avant 9600 Pulse Oximeter | Nonin Medical, Inc. | 2004 | — |
| 0 (this device) | K120052 | Cvinsight | Intelomed, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2010 | 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 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 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K102350 | Pulse OximeterSummary page 1…OQA JOM Common/Usual Name Oximeter Proprietary Name CVlnsight Predicate Device(s) K102350, Nonin Medical 3150 Pulse Oximeter K040589, Nonin Medical 9700 Pulse Oximeter with Pulse Wave f… | 2010 |
| * | K040589 | Modification to Avant 9600 Pulse OximeterSummary page 1…Oximeter Proprietary Name CVlnsight Predicate Device(s) K102350, Nonin Medical 3150 Pulse Oximeter K040589, Nonin Medical 9700 Pulse Oximeter with Pulse Wave form K960884, LSI TeleTrens Model Number TM1… | 2004 |
| * | K960884 | Tele Trens TM 10Summary page 1…50, Nonin Medical 3150 Pulse Oximeter K040589, Nonin Medical 9700 Pulse Oximeter with Pulse Wave form K960884, LSI TeleTrens Model Number TM1O0 K853124, Novamethix Pulse Oximeter, Model 500 Reason for sub… | 1997 |
| * | K853124 | Novametrix Pulse Oximeter, Model 500Summary page 1…589, Nonin Medical 9700 Pulse Oximeter with Pulse Wave form K960884, LSI TeleTrens Model Number TM1O0 K853124, Novamethix Pulse Oximeter, Model 500 Reason for submission New Device Indications For Use The CVlnsight system i… | 1985 |
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 21 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 24 ancestors have a recall of any class.
- 1 other device also cites its predicate K102350.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, 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 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
The CVlnsight system is comprised of a pulse oximeter and a software application installed and operating on a personal computer. The pulse oximeter device is indicated for use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is intended for spot-checking and / or data collection and recording of patients who are well or poorly perfused. The intended use…
Read the full statement (139 words)
The CVlnsight system is comprised of a pulse oximeter and a software application installed and operating on a personal computer. The pulse oximeter device is indicated for use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients. It is intended for spot-checking and / or data collection and recording of patients who are well or poorly perfused. The intended use environments are Hospitals, Medical Facilities, Ambulatory, Sub-Acute, and Sleep Studies. CVlnsight measures, displays, and stores functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate, and provides alarm functionality for these parameters.
Additionally, CVlnsight provides a utility for recording trends of pulse rate, SpO2, and the percentage of change from a user-defined baseline value for values of pulse rate and pulse strength derived from the photoelectric plethysmograph waveform.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120052: Cvinsight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120052
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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