510(k) · Cleared
ClearedRMX Physiological Data Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
S.L.P., Ltd. · MNR Ventilatory Effort Recorder
Cleared on Sep 2, 2008 as substantially equivalent to K033402 (Pro-Tech Services, Inc., 2004) and 3 other predicates after a 203-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Sep 2, 2008
- Review
- 203 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K962603 (1997). 24 ancestors in all, the oldest K863918 (1987). No later device cites it as a predicate yet.
- Root · 5 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 4 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 3 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 2 generations backK992340 Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop…Masimo Corp. · 1999 · Recalled
- 1 generation backK040178 Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch DeviceS.P.O. Medical Equipment, Ltd. · 2004
- This deviceK080375 RMX Physiological Data RecorderS.L.P., Ltd. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −4 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −3 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −2 | K992340 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop… | Masimo Corp. | 1999 | 1 |
| −1 | K040178 | Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch Device | S.P.O. Medical Equipment, Ltd. | 2004 | — |
| 0 (this device) | K080375 | RMX Physiological Data Recorder | S.L.P., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 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 MNR? 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 MNR device
- #1 K244027 Sansa Hsatscore 18.1 · 12 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 |
|---|---|---|---|
| * | K033402 | Portable Sleep Data Recorder (PSDR)Summary page 3…predicate devices without raising any new safety and/or effectiveness issues: 1. Portable sleep data recorder, Pro-tech services Inc., WA, USA, cleared under K033402. 2. DeVilbiss Sleep Recorder,DeVilbiss, PA USA, cleared under K012437. 3. SleepSense Sleep Sensors, S.L.P. LTD., IL, K042253… | 2004 |
| * | K012437 | Devilbiss Sleep Recorder Model # RM60Summary page 3…ss issues: 1. Portable sleep data recorder, Pro-tech services Inc., WA, USA, cleared under K033402. 2. DeVilbiss Sleep Recorder,DeVilbiss, PA USA, cleared under K012437. 3. SleepSense Sleep Sensors, S.L.P. LTD., IL, K042253 4. SPO, Pulse Oximeter, SPO LTD., IL, K040178 Detailed descripti… | 2002 |
| * | K042253 | Sleepsense Sleep SensorsSummary page 3…rvices Inc., WA, USA, cleared under K033402. 2. DeVilbiss Sleep Recorder,DeVilbiss, PA USA, cleared under K012437. 3. SleepSense Sleep Sensors, S.L.P. LTD., IL, K042253 4. SPO, Pulse Oximeter, SPO LTD., IL, K040178 Detailed description of the predicate devices is provided in Section 12 of… | 2004 |
| * | K040178 | Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch DeviceSummary page 3…. 2. DeVilbiss Sleep Recorder,DeVilbiss, PA USA, cleared under K012437. 3. SleepSense Sleep Sensors, S.L.P. LTD., IL, K042253 4. SPO, Pulse Oximeter, SPO LTD., IL, K040178 Detailed description of the predicate devices is provided in Section 12 of this application. 5.5 TECHNOLOGICAL… | 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 11 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 24 ancestors have a recall of any class.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MNR
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MNR
165in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNR
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNR
43in 2025
MAUDE reports naming product code MNR, 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 | 6 | 124 | 2 | 1 |
| 2008 | 14 | 118 | 0 | 0 |
| 2009 | 8 | 89 | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 9 | 90 | 1 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 4 | 161 | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 4 | 229 | 0 | 4 |
| 2016 | 3 | 281 | 0 | 10 |
| 2017 | 4 | 275 | 0 | 4 |
| 2018 | 3 | 147 | 0 | 2 |
| 2019 | 8 | 383 | 0 | 3 |
| 2020 | 5 | 192 | 0 | 5 |
| 2021 | 3 | 137 | 1 | 5 |
| 2022 | 7 | 266 | 0 | 4 |
| 2023 | 6 | 183 | 0 | 13 |
| 2024 | 6 | 217 | 0 | 11 |
| 2025 | 10 | 165 | 0 | 43 |
| 2026 | 5 | 227 | 1 | — |
What is it indicated for?
The RMX is a physiological data recorder intended to collect and record data from multiple physiological channels and additional auxiliary inputs from undesignated channels. It is indicated for use by or on order of a physician. The RMX is intended for use in a supervised (hospital) or unsupervised (home) environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080375 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080375: RMX Physiological Data Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080375
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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