510(k) · Cleared
ClearedBiobeat Platform, BB-613WP Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biobeat Technologies, Ltd. · DQA Oximeter
Cleared on Mar 25, 2022 as substantially equivalent to K190792 (Biobeat Technologies, Ltd., 2019) and 2 other predicates after a 259-day review. Its family tree reaches back 20 generations to 1997. 1 of the 171 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Mar 25, 2022
- Review
- 259 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 20 generations to K962603 (1997). 165 ancestors in all, the oldest K822055 (1982). 5 later devices descend from it, 2 citing it directly. 1 of the 171 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 deviceK212153 Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022
- Descendant · cites it directly · 2 of its ownK242018 UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK222010 Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK260157 LifeLens Physiological MonitorLifeLens Technologies, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK252984 Perin Health System (PHD80060-2)Perin Health Devices, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK241066 BB-613-BPMBiobeat Technologies, Ltd. · 2025
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 deviceK212153 Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022
Class I recalls in this family
- K970209 Capnocheck Plus8 generations back · 1997
Most influential descendants
Showing 5 of 5 · See all- K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024 · cites it directly2descendants
- K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd. · 2022 · cites it directly1descendant
- K260157LifeLens Physiological MonitorLifeLens Technologies, Inc. · 2026 · 2 generations on0descendants
- K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC · 2026 · 2 generations on0descendants
- K241066BB-613-BPMBiobeat Technologies, Ltd. · 2025 · 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) | K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | — |
| +1 | K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024 | — |
| +1 | K222010 | Biobeat Platform-2 and BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | — |
| +2 | K260157 | LifeLens Physiological Monitor | LifeLens Technologies, Inc. | 2026 | — |
| +2 | K252984 | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | 2026 | — |
| +2 | K241066 | BB-613-BPM | Biobeat Technologies, Ltd. | 2025 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K190792 | BB-613WPSummary page 4…ncy physiological signal transmitter and receiver, DRG e 880.2910 Clinical electronic thermometer, FLL Regulatory Class: Class I Predicate Devices Biobeat's BB-613 WP (K190792) (Primary Predicate) Masimo Corporation’s MightySat Rx Fingertip Pulse Oximeter (K181956) (SecondaryPredicate) VitalConnect, Inc,… | 2019 |
| * | K181956 | Masimo MightySat Rx Fingertip Pulse OximeterSummary page 4…rmometer, FLL Regulatory Class: Class I Predicate Devices Biobeat's BB-613 WP (K190792) (Primary Predicate) Masimo Corporation’s MightySat Rx Fingertip Pulse Oximeter (K181956) (SecondaryPredicate) VitalConnect, Inc,’s VitalConnect Platform (K183078) (Secondary Predicate) System Description The Biobeat… | 2019 |
| * | K183078 | VitalConnect Platform, VitalPatch BiosensorSummary page 4…13 WP (K190792) (Primary Predicate) Masimo Corporation’s MightySat Rx Fingertip Pulse Oximeter (K181956) (SecondaryPredicate) VitalConnect, Inc,’s VitalConnect Platform (K183078) (Secondary Predicate) System Description The Biobeat Platform and the BB-613WP Patch sensor include a device that is attached… | 2019 |
What descends from it? (5)
2 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 25 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 25 of the 165 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K242018 (Lifesignals, Inc., 2024) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K190792.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Biobeat Platform is a wireless noninvasive remote monitoring system intended for use by healthcare professionals for spot check collection of physiological data in home and healthcare settings. This can include, functional oxygen saturation of arterial hemoglobin (%Sp02), pulse rate, blood pressure, respiration rate (RRp), and body temperature. The Biobeat Platform tracks changes in blood pressure based on Pulse Wave Transit Time (PWTT) which is…
Read the full statement (137 words)
The Biobeat Platform is a wireless noninvasive remote monitoring system intended for use by healthcare professionals for spot check collection of physiological data in home and healthcare settings. This can include, functional oxygen saturation of arterial hemoglobin (%Sp02), pulse rate, blood pressure, respiration rate (RRp), and body temperature.
The Biobeat Platform tracks changes in blood pressure based on Pulse Wave Transit Time (PWTT) which is obtained utilizing pulse measurements from the integrated SpO2 sensor, following a calibration process using an FDA-cleared oscillometric blood pressure monitor.
The Biobeat Platform is intended for spot-checking and tracking changes of adult patients in hospitals, clinics, long-term care, and at home. The data from the Biobeat Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended for use on critical care patients.
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/K212153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212153: Biobeat Platform, BB-613WP Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212153
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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