510(k) · Cleared
ClearedPerin Health System (PHD80060-2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perin Health Devices, LLC · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jan 22, 2026 as substantially equivalent to K242018 (Lifesignals, Inc., 2024) and 1 other predicate after a 126-day review. Its family tree reaches back 22 generations to 1997. 1 of the 170 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 22, 2026
- Review
- 126 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 22 generations to K962603 (1997). 169 ancestors in all, the oldest K822055 (1982). No later device cites it as a predicate yet. 1 of the 170 devices in this family, counting this one, has a Class I recall.
- Root · 22 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 18 generations between
- 3 generations backK181956 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2019
- 2 generations backK212153 Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022
- 1 generation backK242018 UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024
- This deviceK252984 Perin Health System (PHD80060-2)Perin Health Devices, LLC · 2026
Show all 22 generations
- Root · 22 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 21 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 20 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 19 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 18 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 17 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 16 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 15 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 14 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 13 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 12 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 11 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 10 generations backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- 9 generations backK110516 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 8 generations backK112687 Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 7 generations backK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
- 6 generations backK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
- 5 generations backK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
- 4 generations backK150314 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015
- 3 generations backK181956 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2019
- 2 generations backK212153 Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022
- 1 generation backK242018 UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024
- This deviceK252984 Perin Health System (PHD80060-2)Perin Health Devices, LLC · 2026
Class I recalls in this family
- K970209 Capnocheck Plus10 generations back · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −21 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −20 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −19 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −18 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −17 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −16 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −15 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −14 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −13 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −12 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −11 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
| −10 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | — |
| −9 | K110516 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −8 | K112687 | Connex (R) Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −7 | K121013 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2012 | — |
| −6 | K140188 | Masimo Root Monitoring System | Masimo Corporation | 2014 | — |
| −5 | K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014 | — |
| −4 | K150314 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2015 | — |
| −3 | K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2019 | — |
| −2 | K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | — |
| −1 | K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024 | — |
| 0 (this device) | K252984 | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 5 | 0 |
| 1992 | 4 | 0 |
| 1993 | 4 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 4 | 0 |
| 1997 | 5 | 1 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 15 | 0 |
| 2001 | 3 | 0 |
| 2002 | 10 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 12 | 0 |
| 2006 | 7 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K242018 | UbiqVue™ 2A Multi-parameter System (UX2550)Summary page 6…K252984 510(k) Summary Primary Predicate Device UbiqVue 2A Multiparameter System 510(k) Number K242018 Secondary Predicate Device Alio Medical Remote Monitoring System 510(k) Number K211365 Predicate… | 2024 |
| * | K211365 | Alio Medical Remote Monitoring SystemSummary page 6…parameter System 510(k) Number K242018 Secondary Predicate Device Alio Medical Remote Monitoring System 510(k) Number K211365 Predicate for Auscultation Sound Data Reference Device EKO CORE 500 Digital Stethoscope… | 2022 |
| † | K230111 | CORE 500 Digital Stethoscope | 2023 |
| † | K222010 | Biobeat Platform-2 and BB-613WP Patch | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 10 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 10 companies; a new generation was cleared every 11 months on median.
- 25 of the 169 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K242018.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, 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 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Perin Health Platform is a wireless remote monitoring system intended for use by healthcare professionals for spot check collection of physiological data in healthcare and home settings for long-term monitoring. The Perin Health Patch can monitor auscultation data of heart and lung sounds, photoplethysmography waveforms (PPG), oxygen saturation (%SpO2), heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate…
Read the full statement (189 words)
The Perin Health Platform is a wireless remote monitoring system intended for use by healthcare professionals for spot check collection of physiological data in healthcare and home settings for long-term monitoring. The Perin Health Patch can monitor auscultation data of heart and lung sounds, photoplethysmography waveforms (PPG), oxygen saturation (%SpO2), heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, skin temperature, activity detection (including step count), and posture (body position relative to gravity including fall).
The Perin Health System is intended for spot-checking and tracking changes of adult patients in hospitals, clinics, long-term care, and at home. In home-use environments, the Perin Health Platform is able to integrate with optional third-party devices for blood pressure, and weight data collection via the mobile application. The mobile application transmits data from the Health Patch and third party devices to the cloud and web-based portal for storage, analysis, and review by healthcare professionals. The Perin Health Platform can include the ability to notify healthcare professionals when physiological data falls outside set limits or manual trigger by the patient.
The device is intended to provide physiological information for non-critical, adult population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252984 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252984: Perin Health System (PHD80060-2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252984
Report an extraction error
Are you the manufacturer?
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