510(k) · Cleared
ClearedDR180-R/Oxy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
North East Monitoring, Inc. · FLL Continuous Measurement Thermometer
Cleared on Mar 23, 1999 as substantially equivalent to K960925 (North East Monitoring, Inc., 1996) after a 161-day review. Its family tree reaches back 1 generation to 1996. 40 later devices descend from it.
- Decided
- Mar 23, 1999
- Review
- 161 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960925 (1996). 40 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK960925 Northeast Monitoring DR180North East Monitoring, Inc. · 1996
- This deviceK983576 DR180-R/OxyNorth East Monitoring, Inc. · 1999
- Descendant · cites it directly · 39 of its ownK022274 Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd. · 2003
- Descendant · 2 generations on · 34 of its ownK041308 Remotenurse Patient Monitoring SystemWebvmc, LLC · 2004
- Descendant · 3 generations on · 25 of its ownK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- Descendant · 4 generations on · 12 of its ownK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- Descendant · 4 generations on · 12 of its ownK083115 Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K022274Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd. · 2003 · cites it directly39descendants
- K041308Remotenurse Patient Monitoring SystemWebvmc, LLC · 2004 · 2 generations on34descendants
- K080798Intel Health Guide, Model: PHS6000Intel Corp. · 2008 · 3 generations on25descendants
- K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009 · 4 generations on12descendants
- K083115Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008 · 4 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960925 | Northeast Monitoring DR180 | North East Monitoring, Inc. | 1996 | — |
| 0 (this device) | K983576 | DR180-R/Oxy | North East Monitoring, Inc. | 1999 | — |
| +1 | K022274 | Carecompanion Patient Station & Nurse Station | Neptec Design Group, Ltd. | 2003 | — |
| +2 | K041308 | Remotenurse Patient Monitoring System | Webvmc, LLC | 2004 | — |
| +3 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| +4 | K083862 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2009 | — |
| +4 | K083115 | Modification to Intel Health Guide, Model PHS6000 | Intel Corp. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 FLL? 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 FLL device
- #1 K191829 Microlife Non-Contact Infrared Forehead…score 26.7 · 4 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 |
|---|---|---|---|
| * | K960925 | Northeast Monitoring DR180Summary page 13/0/15 K58 357 510(k) Summary The DR180-R/Oxy Holter and Pulse Oximetry Recorder is the predicate device (DR180 Holter recorder, 510(k) K960925) with the addition of a Nonin Xpod pulse oximetry probe. The probe cable is attached to the DR180 with the electrode lead wires.… | 1996 |
What descends from it? (40)
See all 401 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022274 | Carecompanion Patient Station & Nurse Station | 2003 | 39 |
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?
- Its one ancestor has no recall.
- Of its descendants, K022274 (Neptec Design Group, Ltd., 2003) has gone furthest, with 39 descendants of its own.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FLL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLL
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLL
73in 2025
MAUDE reports naming product code FLL, 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 | 15 | 81 | 0 | 4 |
| 2008 | 14 | 59 | 0 | 13 |
| 2009 | 13 | 84 | 0 | 9 |
| 2010 | 24 | 88 | 0 | 9 |
| 2011 | 20 | 113 | 1 | 18 |
| 2012 | 17 | 126 | 0 | 26 |
| 2013 | 14 | 149 | 0 | 16 |
| 2014 | 7 | 199 | 0 | 54 |
| 2015 | 3 | 270 | 1 | 53 |
| 2016 | 22 | 157 | 0 | 58 |
| 2017 | 16 | 174 | 2 | 118 |
| 2018 | 35 | 209 | 1 | 51 |
| 2019 | 22 | 198 | 5 | 52 |
| 2020 | 21 | 194 | 0 | 53 |
| 2021 | 43 | 218 | 0 | 115 |
| 2022 | 24 | 218 | 0 | 142 |
| 2023 | 17 | 295 | 0 | 101 |
| 2024 | 13 | 223 | 0 | 118 |
| 2025 | 6 | 131 | 1 | 73 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
1.) Detection of Arrhythmias: The NorthEast Monitoring DR180-R/Oxy is indicated for use for long-term monitoring of cardiac rhythm when intermittent arrhythmias are suspected due to patient symptoms such as palpitations, transient ischemic attacks (TIA’s), syncope (fainting), or other such symptoms as determined by the physician. 2.) Efficacy of Treatment: The NorthEast Monitoring DR180-R/Oxy is indicated for use to determine if current pharmacological…
Read the full statement (174 words)
1.) Detection of Arrhythmias: The NorthEast Monitoring DR180-R/Oxy is indicated for use for long-term monitoring of cardiac rhythm when intermittent arrhythmias are suspected due to patient symptoms such as palpitations, transient ischemic attacks (TIA’s), syncope (fainting), or other such symptoms as determined by the physician.
2.) Efficacy of Treatment: The NorthEast Monitoring DR180-R/Oxy is indicated for use to determine if current pharmacological treatment of known arrhythmias is effective by measuring the frequency and duration of the arrhythmia compared to the frequency and duration prior to treatment.
3.) Pacemaker Evaluation: The NorthEast Monitoring DR180-R/Oxy is indicated for use to evaluate the function of implanted pacemakers to insure that the pacemaker is functioning within prescribed limits.
'4.) Trending of oxygen saturation (SpO2) in the blood for periods of up to 24 hours. If the device is to be used for home monitoring, periods of activity or excessive movement are to be omitted due to the artifact that would be generated.
3.) The NorthEast Monitoring DR180-R/Oxy is to be used only on the order of a physician.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983576: DR180-R/Oxy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983576
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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