510(k) · Cleared
ClearedPersonalized Physiology Analytics Engine software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vgbio, Inc (Dba Physiq) · PLB Multivariate Vital Signs Index
Cleared on Jun 11, 2015 as substantially equivalent to K053112 (Oxford Biosignals Limited, 2006) and 1 other predicate after a 276-day review. Its family tree reaches back 7 generations to 1997. 3 later devices descend from it.
- Decided
- Jun 11, 2015
- Review
- 276 days
- Class
- Class II
- Product code
- PLB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K962603 (1997). 36 ancestors in all, the oldest K891104 (1989). 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 6 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 5 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 4 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 3 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 2 generations backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- 1 generation backK081140 VisensiaObs Medical · 2008
- This deviceK142512 Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq) · 2015
- Descendant · cites it directly · 2 of its ownK183282 Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK230386 SpassageQSpass, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK240558 NavoycdsAlgodx AB · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −6 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −5 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −4 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −3 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −2 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| −1 | K081140 | Visensia | Obs Medical | 2008 | — |
| 0 (this device) | K142512 | Personalized Physiology Analytics Engine software | Vgbio, Inc (Dba Physiq) | 2015 | — |
| +1 | K183282 | Biovitals Analytics Engine | Biofourmis Singapore Pte., Ltd. | 2019 | — |
| +2 | K230386 | SpassageQ | Spass, Inc. | 2023 | — |
| +3 | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K053112 | BiosignSummary page 5…ion: Class II, 21 CFR§870.2300, Cardiac monitor (including cardiotachometer and rate alarm) Product Code: PLB PREDICATE DEVICES Oxford BioSignals Ltd, BioSign™ (K053112) OBS Medical, Visensia® with Alert (K081140) K142512… | 2006 |
| * | K081140 | VisensiaSummary page 5…cluding cardiotachometer and rate alarm) Product Code: PLB PREDICATE DEVICES Oxford BioSignals Ltd, BioSign™ (K053112) OBS Medical, Visensia® with Alert (K081140) K142512 p.3/7 510(k) SUMMARY… | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183282 | Biovitals Analytics Engine | 2019 | 2 |
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 18 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 36 ancestors have a recall of any class.
- Of its descendants, K183282 (Biofourmis Singapore Pte., Ltd., 2019) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K053112.
How does its category compare?
All PLB devicesPLB Multivariate Vital Signs Index: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Personalized Physiology Engine (PPA Engine) is intended to be used with data from already cleared sensors measuring physiological parameters, including heart rate, respiratory rate, and activity in ambulatory patients being monitored in a healthcare facility or at home. The device provides a time series Multivariate Change Index (MCI) which indicates whether the relationships among the patient’s monitored vital signs change from those measured at…
Read the full statement (159 words)
The Personalized Physiology Engine (PPA Engine) is intended to be used with data from already cleared sensors measuring physiological parameters, including heart rate, respiratory rate, and activity in ambulatory patients being monitored in a healthcare facility or at home. The device provides a time series Multivariate Change Index (MCI) which indicates whether the relationships among the patient’s monitored vital signs change from those measured at baseline, which has been derived from measurements previously obtained during routine activities of daily living. The MCI is based on an integrated computation evaluating changes in the parameters and their relationships to each other.
The PPA Engine is an adjunct to and is not intended to replace vital signs monitoring. The MCI is intended for daily intermittent, retrospective review by a qualified practitioner. The PPA Engine is intended to provide additional information for use during routine patient monitoring. The MCI is not intended for making clinical decisions regarding patient treatment or for diagnostic purposes.
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/K142512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142512: Personalized Physiology Analytics Engine software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142512
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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