510(k) · Cleared
ClearedSpassageQ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spass, Inc. · PLB Multivariate Vital Signs Index
Cleared on Jun 15, 2023 as substantially equivalent to K183282 (Biofourmis Singapore Pte., Ltd., 2019) after a 121-day review. Its family tree reaches back 9 generations to 1997. 1 later device descends from it.
- Decided
- Jun 15, 2023
- Review
- 121 days
- Class
- Class II
- Product code
- PLB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K962603 (1997). 38 ancestors in all, the oldest K891104 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations between
- 3 generations backK081140 VisensiaObs Medical · 2008
- 2 generations backK142512 Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq) · 2015
- 1 generation backK183282 Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd. · 2019
- This deviceK230386 SpassageQSpass, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK240558 NavoycdsAlgodx AB · 2024
Show all 9 generations
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 8 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 7 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 6 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 5 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 4 generations backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- 3 generations backK081140 VisensiaObs Medical · 2008
- 2 generations backK142512 Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq) · 2015
- 1 generation backK183282 Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd. · 2019
- This deviceK230386 SpassageQSpass, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K240558NavoycdsAlgodx AB · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −8 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −7 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −6 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −5 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −4 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| −3 | K081140 | Visensia | Obs Medical | 2008 | — |
| −2 | K142512 | Personalized Physiology Analytics Engine software | Vgbio, Inc (Dba Physiq) | 2015 | — |
| −1 | K183282 | Biovitals Analytics Engine | Biofourmis Singapore Pte., Ltd. | 2019 | — |
| 0 (this device) | K230386 | SpassageQ | Spass, Inc. | 2023 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K183282 | Biovitals Analytics EngineSummary page 4…21 CFR 870.2300 Regulatory Class: Class II Classification Panel: Cardiovascular 3. PREDICATE DEVICE 510(k) number: K183282 Trade name: Biovitals Analytics Engine Product Code / Classification: PLB / Class II, 21 CFR 870.230… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240558 | Navoycds | 2024 | 0 |
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 26 years and passes through 9 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 38 ancestors have a recall of any class.
- Of its descendants, K240558 (Algodx AB, 2024) has gone furthest, with 0 descendants 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. 2023, 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 SpassageQ is intended to be used with patient data from already cleared patient monitoring devices which measure respiratory rate, systolic blood pressure, and Glasgow Coma Scale (GCS) in patients being monitored in a healthcare facility. The device provides qSOFA score (also known as quickSOFA) which indicates patients with suspected infection who are at greater risk for a poor outcome. It uses three criteria, assigning one point for low blood…
Read the full statement (142 words)
The SpassageQ is intended to be used with patient data from already cleared patient monitoring devices which measure respiratory rate, systolic blood pressure, and Glasgow Coma Scale (GCS) in patients being monitored in a healthcare facility. The device provides qSOFA score (also known as quickSOFA) which indicates patients with suspected infection who are at greater risk for a poor outcome. It uses three criteria, assigning one point for low blood pressure (SBP≤100 mmHg), high respiratory rate (≥22 breaths per min), or altered mentation (Glasgow coma scale<15).
The SpassageQ is an adjunct to and is not intended to replace vital signs monitoring. The device is intended to provide additional information for use during patient monitoring in a healthcare facility. The device 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 as stated in the FDA summary.
https://510kreport.com/device/K230386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230386: SpassageQ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230386
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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