510(k) · Cleared
ClearedBiovitals Analytics Engine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofourmis Singapore Pte., Ltd. · PLB Multivariate Vital Signs Index
Cleared on Aug 15, 2019 as substantially equivalent to K142512 (Vgbio, Inc (Dba Physiq), 2015) after a 262-day review. Its family tree reaches back 8 generations to 1997. 2 later devices descend from it.
- Decided
- Aug 15, 2019
- Review
- 262 days
- Class
- Class II
- Product code
- PLB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K962603 (1997). 37 ancestors in all, the oldest K891104 (1989). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 7 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 6 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 5 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 4 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 3 generations backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- 2 generations backK081140 VisensiaObs Medical · 2008
- 1 generation backK142512 Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq) · 2015
- This deviceK183282 Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK230386 SpassageQSpass, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK240558 NavoycdsAlgodx AB · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −7 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −6 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −5 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −4 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −3 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| −2 | K081140 | Visensia | Obs Medical | 2008 | — |
| −1 | K142512 | Personalized Physiology Analytics Engine software | Vgbio, Inc (Dba Physiq) | 2015 | — |
| 0 (this device) | K183282 | Biovitals Analytics Engine | Biofourmis Singapore Pte., Ltd. | 2019 | — |
| +1 | K230386 | SpassageQ | Spass, Inc. | 2023 | — |
| +2 | K240558 | Navoycds | Algodx AB | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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 PLB? 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 PLB device
- #1 K240756 Aitrics-VCscore 16.4 · 30 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 |
|---|---|---|---|
| * | K142512 | Personalized Physiology Analytics Engine softwareSummary page 4…Name(s): Cardiovascular Product Code/ Regulation: PLB/21 CFR 870.2300 Classification: Class II Predicate Device: • PhysIQ PPA Engine – K142512 Device Description: Biovitals Analytics Engine consists of: • An automated proprietary algorithm to analyze data and gene… | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230386 | SpassageQ | 2023 | 1 |
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 22 years and passes through 8 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 37 ancestors have a recall of any class.
- Of its descendants, K230386 (Spass, Inc., 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All PLB devicesPLB Multivariate Vital Signs Index: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · PLB
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PLB
Too few PLB 510(k)s in any year since 2007 to give a median.
Recalls per year · PLB
No recall names PLB since 2007.
Adverse event reports per year · PLB
No MAUDE report names PLB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Biovitals Analytic Engine (BA Engine) is intended to be used with continuous biometric data from already cleared sensors measuring heart rate, respiratory rate, and activity in ambulatory patients being monitored in a healthcare facility or at home, during periods of minimal activity. The device learns the correlation between multiple vital signs during the patient’s daily activity and builds an individualized biometric signature which is dynamically…
Read the full statement (179 words)
The Biovitals Analytic Engine (BA Engine) is intended to be used with continuous biometric data from already cleared sensors measuring heart rate, respiratory rate, and activity in ambulatory patients being monitored in a healthcare facility or at home, during periods of minimal activity. The device learns the correlation between multiple vital signs during the patient’s daily activity and builds an individualized biometric signature which is dynamically updated based on incoming data. The device computes a time series Biovitals Index (BI), which reflects changes in the patient’s measured vital signs from their measured baseline, which is derived from the individualized biometric signature of the patient.
The BA Engine is a cloud-based software engine, intended to be an adjunct to and is not intended to replace vital signs monitoring. The BI is intended for daily intermittent, retrospective review by a qualified practitioner. The BA Engine is intended to provide additional information for use during routine patient monitoring. The BI is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes.
The device is intended for an adult population.
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/K183282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183282: Biovitals Analytics Engine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183282
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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