510(k) · Cleared
ClearedNeteera 130H-Plus Vital Sign Monitoring Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neteera Technologies, Ltd. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Feb 9, 2024 as substantially equivalent to K212143 (Neteera Technologies, Ltd., 2022) after a 241-day review. Its family tree reaches back 6 generations to 1983.
- Decided
- Feb 9, 2024
- Review
- 241 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K830295 (1983). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK830295 Medilog 9000 SystemOxford Medilog, Inc. · 1983
- 5 generations backK971813 EMBLAFerguson Medical · 1998
- 4 generations backK070375 Earlysense ES-16 SystemEarlysense, Ltd. · 2007
- 3 generations backK082626 PAM 3000Wireless 2000 RF & Uwb Technologies, Ltd. · 2009
- 2 generations backK202464 Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc. · 2021
- 1 generation backK212143 Neteera 130H/131H Vital Sign Monitoring SensorNeteera Technologies, Ltd. · 2022
- This deviceK231733 Neteera 130H-Plus Vital Sign Monitoring SensorNeteera Technologies, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K830295 | Medilog 9000 System | Oxford Medilog, Inc. | 1983 | — |
| −5 | K971813 | EMBLA | Ferguson Medical | 1998 | — |
| −4 | K070375 | Earlysense ES-16 System | Earlysense, Ltd. | 2007 | — |
| −3 | K082626 | PAM 3000 | Wireless 2000 RF & Uwb Technologies, Ltd. | 2009 | — |
| −2 | K202464 | Vital Sign Monitoring Sensor (Model :XK300) | Xandar Kardian, Inc. | 2021 | — |
| −1 | K212143 | Neteera 130H/131H Vital Sign Monitoring Sensor | Neteera Technologies, Ltd. | 2022 | — |
| 0 (this device) | K231733 | Neteera 130H-Plus Vital Sign Monitoring Sensor | Neteera Technologies, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K212143 | Neteera 130H/131H Vital Sign Monitoring SensorSummary page 4…Device Class: 2 Classification Panel: Cardiovascular 4. Legally Marketed Predicate Device(s): Neteera’s Vital Sign Monitoring Sensor Model: 130H (K212143) 5. Indication for Use Statement: The Neteera 130H-Plus device is intended for spot and continuous measurement of hea… | 2022 |
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 41 years and passes through 6 companies; a new generation was cleared every 9.8 years on median.
- 1 of the 20 ancestors has a recall of any class.
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. 2024, this device’s year, is highlighted.
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 Neteera 130H-Plus device is intended for spot and continuous measurement of heart rate and respiration rate in adult patients (in healthcare facilities and home monitoring) and inform on bed exit.
The indications provided are to be used by health care professionals and are intended to be reviewed by clinicians to inform patient care.
The Neteera device is not intended to be used as an alarm system for potentially acute life-threatening situations in which medical intervention is necessary (e.g., ICU).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231733 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231733: Neteera 130H-Plus Vital Sign Monitoring Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231733
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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