510(k) · Cleared
ClearedNT1D Vital Signs Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Tech, Inc. · DQA Oximeter
Cleared on Aug 27, 2013 as substantially equivalent to K032971 (Respironics Novametrix, Inc., 2004) and 3 other predicates after a 260-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Aug 27, 2013
- Review
- 260 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K001359 (2000). 13 ancestors in all, the oldest K920379 (1992). No later device cites it as a predicate yet.
- Root · 5 generations backK001359 Dash 3000/4000 Patient MonitorGeneral Electric Medical Systems Information Techn · 2000 · Recalled
- 4 generations backK020290 Dash 3000/4000 Patient MonitorGeneral Electric Medical Systems Information Techn · 2002 · Recalled
- 3 generations backK030431 Modification to Dash 3000/4000 Patient MonitorGe Medical Systems Information Technologies · 2003 · Recalled
- 2 generations backK042417 Zoll M Series ETC02 Loflo OptionZoll Medical Corp · 2004
- 1 generation backK053174 Loflo C5 CO2 SensorRespironics Novametrix, LLC · 2006 · Recalled
- This deviceK123797 NT1D Vital Signs MonitorNew Tech, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001359 | Dash 3000/4000 Patient Monitor | General Electric Medical Systems Information Techn | 2000 | 1 |
| −4 | K020290 | Dash 3000/4000 Patient Monitor | General Electric Medical Systems Information Techn | 2002 | 1 |
| −3 | K030431 | Modification to Dash 3000/4000 Patient Monitor | Ge Medical Systems Information Technologies | 2003 | 1 |
| −2 | K042417 | Zoll M Series ETC02 Loflo Option | Zoll Medical Corp | 2004 | — |
| −1 | K053174 | Loflo C5 CO2 Sensor | Respironics Novametrix, LLC | 2006 | 2 |
| 0 (this device) | K123797 | NT1D Vital Signs Monitor | New Tech, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 2 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K032971 | Tidal Wave SP Model 710/715 and 715Summary page 2…21 C.F.R. 870.2700 3.0 Predicate Device Information 1. TidalWave SP pulse oximeter / carbon dioxide monitor Models 710/715 (510(k) No. K03297 1), dated 8/26,2004 2. SOLARIS NTI and NTIA Handheld Pulse Oximeter with sensor accessories (510(k) No. K073249), d… | 2004 |
| * | K073249 | Solaris NT1 and NT1A Handheld Pulse Oximeters with Sensor AccessoriesSummary page 2…onitor Models 710/715 (510(k) No. K03297 1), dated 8/26,2004 2. SOLARIS NTI and NTIA Handheld Pulse Oximeter with sensor accessories (510(k) No. K073249), dated 7/25,2008 3. Capnostat 5 CO 2 Sensor (5 10(k) No. K042601), dated 11/19,2004, LoFlo C5 CO 2 Sensor, (510… | 2008 |
| * | K042601 | Capnostat 5Summary page 2…2. SOLARIS NTI and NTIA Handheld Pulse Oximeter with sensor accessories (510(k) No. K073249), dated 7/25,2008 3. Capnostat 5 CO 2 Sensor (5 10(k) No. K042601), dated 11/19,2004, LoFlo C5 CO 2 Sensor, (510(k) No. K0531I74),dated 1/12,2006 4.0 Device description NTI… | 2004 |
| * | K053174 | Loflo C5 CO2 SensorSummary page 5…he mainstream CO 2 sensor is Capnostat 5 C02 Sensor, which 510(k) No. is K04260 I The sidestream CO 2 sensor is LOFlo C5 C02 Sensor, which 510(k) No. is K053 174. The notable difference between the NTI D and the predicate device is wireless transmission fuction. About this… | 2006 |
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 13 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 8 of the 13 ancestors have a recall of any class.
- 3 other devices also cite its predicate K032971.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
NTI D is a handheid vita! signs monitor that continuously monitors end tidal carbon dioxide (EtCO2), respiratory rate (RR), oxygen saturation (SpO2), and pulse rate. The unit is intended for monitoring only . The unit transfers history data to PC through aUSB adapter. It is for use in any environment where continuous, noninvasive monitoring of these parameters is desired, including hospital and hospital-type facilities. The monitor is intended for use on adult and pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123797 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123797: NT1D Vital Signs Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123797
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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