510(k) · Cleared
ClearedPiconibp Oem Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medizin Systeme Boeblingen GmbH · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Sep 14, 2005 as substantially equivalent to K020531 (Philips Medical Systems, 2002) and 2 other predicates after a 112-day review. Its family tree reaches back 7 generations to 1994. 10 later devices descend from it.
- Decided
- Sep 14, 2005
- Review
- 112 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K941811 (1994). 36 ancestors in all, the oldest K872781 (1987). 10 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 6 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 5 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 4 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 3 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 2 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 1 generation backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- This deviceK051366 Piconibp Oem ModulePhilips Medizin Systeme Boeblingen GmbH · 2005
- Descendant · cites it directly · 9 of its ownK052795 Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH · 2005 · Recalled
- Descendant · 2 generations on · 8 of its ownK062137 Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH · 2006 · Recalled
- Descendant · 2 generations on · 7 of its ownK071800 Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · Recalled
- Descendant · 3 generations on · 4 of its ownK100420 Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH · 2010
- Descendant · 2 generations on · 3 of its ownK092028 Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH · 2010
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K052795Philips Avalon Fetal Monitor, Models FM20 and FM30Philips Medizin Systeme Boeblingen GmbH · 2005 · cites it directly9descendants
- K062137Modification to Philips Avalon Fetal Monitors FM20 and FM30Philips Medizin Systeme Boeblingen GmbH · 2006 · 2 generations on8descendants
- K071800Philips Avalon Fetal Monitors FM20 and FM30Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · 2 generations on7descendants
- K100420Philips Obtracevue Model SW Rev. G.00Philips Medizin Systeme Boeblingen GmbH · 2010 · 3 generations on4descendants
- K092028Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50Philips Medizin Systeme Boeblingen GmbH · 2010 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −6 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −5 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −4 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −3 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −2 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −1 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| 0 (this device) | K051366 | Piconibp Oem Module | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| +1 | K052795 | Philips Avalon Fetal Monitor, Models FM20 and FM30 | Philips Medizin Systeme Boeblingen GmbH | 2005 | 1 |
| +2 | K062137 | Modification to Philips Avalon Fetal Monitors FM20 and FM30 | Philips Medizin Systeme Boeblingen GmbH | 2006 | 2 |
| +2 | K071800 | Philips Avalon Fetal Monitors FM20 and FM30 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | 4 |
| +3 | K100420 | Philips Obtracevue Model SW Rev. G.00 | Philips Medizin Systeme Boeblingen GmbH | 2010 | — |
| +2 | K092028 | Philips Avalon Fetal Monitors FM20, FM30, FM40, and FM50 | Philips Medizin Systeme Boeblingen GmbH | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 7 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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 DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 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 |
|---|---|---|---|
| * | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release…Summary page 1…OEM module is in respect of non-invasive blood pressure (NIBP) substantially equivalent to previously cleared Philips Multi-Parameter Module M3001A marketed pursuant to K020531 (March 20, 2002) and Philips Measurement Server M3000A K001333 (May, 17, 2000). The new device is in respect of pulse rate subst… | 2002 |
| * | K001333 | Agilent Component Monitoring System, Agilent Multi-Measurement Server and Compact…Summary page 1…substantially equivalent to previously cleared Philips Multi-Parameter Module M3001A marketed pursuant to K020531 (March 20, 2002) and Philips Measurement Server M3000A K001333 (May, 17, 2000). The new device is in respect of pulse rate substantially equivalent to the Philips Series 5OXM (M1350B) Fetal/Ma… | 2000 |
| * | K954351 | Series 50XMSummary page 1…ent Server M3000A K001333 (May, 17, 2000). The new device is in respect of pulse rate substantially equivalent to the Philips Series 5OXM (M1350B) Fetal/Maternal Monitor K954351 (March 08, 1996). 4. The new device picoNIBP OEM module reuses the NIBP portion and the NIBP algorithm of the legally marketed P… | 1996 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052795 | Philips Avalon Fetal Monitor, Models FM20 and FM30 | 2005 | 9 |
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 11 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 36 ancestors has a recall of any class.
- Of its descendants, K052795 (Philips Medizin Systeme Boeblingen GmbH, 2005) has gone furthest, with 9 descendants of its own.
- 6 other devices also cite its predicate K020531.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
Indicated for use by health care professionals whenever there is a need for measuring the non-invasive blood pressure and pulse rate of patients. It is intended for use in patient monitors for measurement of blood pressure and for calculation of pulse rate of adults, pediatrics, and neonates in health care facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051366: Piconibp Oem Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051366
Report an extraction error
Are you the manufacturer?
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