510(k) · Cleared
ClearedBiosign
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oxford Biosignals Limited · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Jan 31, 2006 as substantially equivalent to K012451 (Welch Allyn Protocol, Inc., 2001) and 2 other predicates after an 88-day review. Its family tree reaches back 5 generations to 1997. 8 later devices descend from it.
- Decided
- Jan 31, 2006
- Review
- 88 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K962603 (1997). 20 ancestors in all, the oldest K912639 (1991). 8 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 4 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 3 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 2 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 1 generation backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- This deviceK053112 BiosignOxford Biosignals Limited · 2006
- Descendant · cites it directly · 3 of its ownK142512 Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq) · 2015
- Descendant · 2 generations on · 2 of its ownK183282 Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd. · 2019
- Descendant · cites it directly · 2 of its ownK124038 Bedside Paediatric Early Warning System (Bedsidepews)Bedside Clinical Systems, Inc. · 2013
- Descendant · 3 generations on · 1 of its ownK230386 SpassageQSpass, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK172959 PeraServer and PeraTrendPerahealth, Inc. · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K142512Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq) · 2015 · cites it directly3descendants
- K183282Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd. · 2019 · 2 generations on2descendants
- K124038Bedside Paediatric Early Warning System (Bedsidepews)Bedside Clinical Systems, Inc. · 2013 · cites it directly2descendants
- K230386SpassageQSpass, Inc. · 2023 · 3 generations on1descendant
- K172959PeraServer and PeraTrendPerahealth, Inc. · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −4 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −3 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −2 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −1 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| 0 (this device) | K053112 | Biosign | Oxford Biosignals Limited | 2006 | — |
| +1 | K142512 | Personalized Physiology Analytics Engine software | Vgbio, Inc (Dba Physiq) | 2015 | — |
| +2 | K183282 | Biovitals Analytics Engine | Biofourmis Singapore Pte., Ltd. | 2019 | — |
| +1 | K124038 | Bedside Paediatric Early Warning System (Bedsidepews) | Bedside Clinical Systems, Inc. | 2013 | — |
| +3 | K230386 | SpassageQ | Spass, Inc. | 2023 | — |
| +2 | K172959 | PeraServer and PeraTrend | Perahealth, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 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 |
|---|---|---|---|
| * | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Summary page 2…Substantial Equivalence The BioSignTM device is substantially equivalent to the following devices: Propaq 200 Series Monitors (1K012451) multi-parameter physiological patient monitors. BioSignTM is a software accessory to multi-parameter physiolog… | 2001 |
| * | K992607 | Sonicaid System 8002Summary page 2…BioSignTM additionally provides a real time trend display of the data fusion of these vital signs. Sonicaid System 8002 (K(992607) is a software accessory for the computerized analysis of antepartumn cardiotocograms (CTGs). It informs the cl… | 2001 |
| * | K030267 | Eeg Monitor with Bis, Model a-2000Summary page 2…o a clinician in the determination of normality based on a model derived from historic clinical data. A-2000 EEG Monitor with HIS (K(030267) is an EEG monitoring system that monitors the state of the brain of an anesthetized or sedated patient. Raw EE… | 2004 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 9 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K142512 (Vgbio, Inc (Dba Physiq), 2015) has gone furthest, with 3 descendants of its own.
- 12 other devices also cite its predicate K012451.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
BioSign TM is an accessory to a multi-parameter patient monitor (bedside or ambulatory) or clinical information system and is indicated for use by health care professionals with those non-pediatric high dependency care patients for whom multi-parameter patient monitoring has been routine. BioSign T M provides the clinician with a trend graph of the patient status index based on a weighted average of five vital signs namely heart rate, respiration rate…
Read the full statement (116 words)
BioSign TM is an accessory to a multi-parameter patient monitor (bedside or ambulatory) or clinical information system and is indicated for use by health care professionals with those non-pediatric high dependency care patients for whom multi-parameter patient monitoring has been routine.
BioSign T M provides the clinician with a trend graph of the patient status index based on a weighted average of five vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The patient status indexTM is a single measure of the patient's condition and represents how different the patient's vital signs are with respect to normality. BioSign TM is an adjunct to and is not intended to replace vital signs monitoring
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053112: Biosign.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053112
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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