510(k) · Cleared
ClearedLoop System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spry Health, Inc. · DQA Oximeter
Cleared on Mar 29, 2019 as substantially equivalent to K181956 (Masimo Corporation, 2019) after a 311-day review. Its family tree reaches back 20 generations to 1997. 1 of the 122 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.
- Decided
- Mar 29, 2019
- Review
- 311 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 20 generations to K962603 (1997). 111 ancestors in all, the oldest K853990 (1985). 10 later devices descend from it, 4 citing it directly. 1 of the 122 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 16 generations between
- 3 generations backK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
- 2 generations backK150314 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015
- 1 generation backK181956 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2019
- This deviceK181352 Loop SystemSpry Health, Inc. · 2019
- Descendant · cites it directly · 7 of its ownK221282 Empatica Health Monitoring PlatformEmpatica S.r.l. · 2022
- Descendant · cites it directly · 4 of its ownK230457 Empatica Health Monitoring Platform; EmbracePlus; Empatica Care…Empatica S.r.l. · 2023
- Descendant · 2 generations on · 1 of its ownK252981 EmbraceMiniEmpatica S.r.l. · 2025
- Descendant · 2 generations on · 1 of its ownK232915 EpiMonitorEmpatica S.r.l. · 2024
- Descendant · 2 generations on · 0 of its ownK260374 Empatica Health Monitoring Platform for Parkinson's Disease…Empatica S.r.l. · 2026
Show all 20 generations
- Root · 20 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 19 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 18 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 17 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 16 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 15 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 14 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 13 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 12 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 11 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 10 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 9 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 8 generations backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- 7 generations backK110516 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 6 generations backK112687 Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 5 generations backK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
- 4 generations backK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
- 3 generations backK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
- 2 generations backK150314 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015
- 1 generation backK181956 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2019
- This deviceK181352 Loop SystemSpry Health, Inc. · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K970209 Capnocheck Plus8 generations back · 1997
Most influential descendants
Showing 5 of 10 · See all- K221282Empatica Health Monitoring PlatformEmpatica S.r.l. · 2022 · cites it directly7descendants
- K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l. · 2023 · cites it directly4descendants
- K252981EmbraceMiniEmpatica S.r.l. · 2025 · 2 generations on1descendant
- K232915EpiMonitorEmpatica S.r.l. · 2024 · 2 generations on1descendant
- K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −19 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −18 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −17 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −16 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −15 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −14 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −13 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −12 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −11 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −10 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −9 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
| −8 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | — |
| −7 | K110516 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −6 | K112687 | Connex (R) Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −5 | K121013 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2012 | — |
| −4 | K140188 | Masimo Root Monitoring System | Masimo Corporation | 2014 | — |
| −3 | K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014 | — |
| −2 | K150314 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2015 | — |
| −1 | K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2019 | — |
| 0 (this device) | K181352 | Loop System | Spry Health, Inc. | 2019 | — |
| +1 | K221282 | Empatica Health Monitoring Platform | Empatica S.r.l. | 2022 | — |
| +1 | K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2023 | — |
| +2 | K252981 | EmbraceMini | Empatica S.r.l. | 2025 | — |
| +2 | K232915 | EpiMonitor | Empatica S.r.l. | 2024 | — |
| +2 | K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring… | Empatica S.r.l. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 1 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 1 | 0 |
| 2002 | 8 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 8 | 0 |
| 2006 | 5 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter Cleared while this submission was under review Summary page 4…ice Common Name: Oximeter Breathing Frequency Monitor Predicate Device Premarket Notification # K181956 Predicate Device Classification: 21 CFR 870.2700: Oximeter 21 CF… | 2019 |
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 8 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 18 of the 111 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K221282 (Empatica S.r.l., 2022) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K181956.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
The Loop System is intended for adult patients in the home environment for passive, non-invasive, intermittent data collection of physiological parameters that will later be transmitted to a web server for remote review by a clinician.
The Loop System measures and records:
• arterial oxygen saturation (SpO2)
• heart rate (HR)
• respiration rate (RR)
All of these measurements are made when no motion is detected by the System.
The Loop System device does not provide physiological alarms
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181352 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181352: Loop System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181352
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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