510(k) · Cleared
ClearedGalaxy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics Inc., Sleep & Home Respiratory Group · MNR Ventilatory Effort Recorder
Cleared on Jan 26, 2009 as substantially equivalent to K061996 (Eb Neuro S.P.A., 2006) after a 28-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Jan 26, 2009
- Review
- 28 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K962603 (1997). 12 ancestors in all, the oldest K930790 (1994). 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 backK040595 ALICE 5Respironics, Inc. · 2004 · Recalled
- 1 generation backK061996 Sandman PocketEb Neuro S.P.A. · 2006
- This deviceK083874 GalaxyRespironics Inc., Sleep & Home Respiratory Group · 2009
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 | K040595 | ALICE 5 | Respironics, Inc. | 2004 | 1 |
| −1 | K061996 | Sandman Pocket | Eb Neuro S.P.A. | 2006 | — |
| 0 (this device) | K083874 | Galaxy | Respironics Inc., Sleep & Home Respiratory Group | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 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 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? (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 |
|---|---|---|---|
| * | K061996 | Sandman PocketSummary page 1…Class II Appropriate Classification Panel Anesthesiology Product Code MNR Predicate Devices EB Neuro, S.p.A. Sandman Pocket (K061996) Reason for submission New device ©2008 Respironics Inc. 12/22/08… | 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 12 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 2 other devices also cite its predicate K061996.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Galaxy is a physiological data recorder intended to collect and record data from multiple physiological channels. It is intended for use by or on the order of a physician. The Galaxy 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/K083874 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083874: Galaxy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083874
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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