510(k) · Cleared
ClearedAdvanced Nibp Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Medical, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Mar 29, 1999 as substantially equivalent to K955113 (Johnson & Johnson Medical, Inc., 1996) and 1 other predicate after a 243-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Mar 29, 1999
- Review
- 243 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K896030 (1989). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK896030 Hewlett-Packard Model M1016A CO2 & M1017A FI02Hewlett-Packard Co. · 1989
- 2 generations backK955113 Dinamap Select Multi-Parameter SystemJohnson & Johnson Medical, Inc. · 1996
- 1 generation backK971569 Dinamap MPS Portable MonitorJohnson & Johnson Medical, Inc. · 1997
- This deviceK982641 Advanced Nibp ModuleJohnson & Johnson Medical, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K896030 | Hewlett-Packard Model M1016A CO2 & M1017A FI02 | Hewlett-Packard Co. | 1989 | — |
| −2 | K955113 | Dinamap Select Multi-Parameter System | Johnson & Johnson Medical, Inc. | 1996 | — |
| −1 | K971569 | Dinamap MPS Portable Monitor | Johnson & Johnson Medical, Inc. | 1997 | — |
| 0 (this device) | K982641 | Advanced Nibp Module | Johnson & Johnson Medical, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 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? (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 |
|---|---|---|---|
| * | K955113 | Dinamap Select Multi-Parameter SystemSummary page 2…hnson Medical, Inc. 510(k) K971569. The DINAMAP MPS Select Multiparameter System received market clearance on August 15, 1996 via Johnson & Johnson Medical. Inc. 510(k) K955113. t ’ Device - Manufacturer 510(k) DINAMAP MPS Select Johnson & Johnson Medical, Inc. | K955113 Multiparameter System DINAMAP MP… | 1996 |
| * | K971569 | Dinamap MPS Portable MonitorSummary page 2…ameter System. The DINAMAP MPS Select Portable Monitor received market clearance on September 19, 1997 via Critikon, a D1v;s1on of Johnson & Johnson Medical, Inc. 510(k) K971569. The DINAMAP MPS Select Multiparameter System received market clearance on August 15, 1996 via Johnson & Johnson Medical. Inc. 5… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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 10 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 2 other devices also cite its predicate K955113.
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?
The Advanced NIBP Module is designed for use with the DINAMAP MPS™ Select™ Family of Monitors, including the DINAMAP MPS Select Portable Monitor and the DINAMAP MPS Select Multiparameter System. The Advanced NIBP Module is intended to obtain a single patient’s systolic, diastolic and mean arterial blood pressures and pulse rate in the same intended use environment as the DINAMAP MPS Select Family of Monitors: hospital, outpatient surgery and healthcare…
Read the full statement (121 words)
The Advanced NIBP Module is designed for use with the DINAMAP MPS™ Select™ Family of Monitors, including the DINAMAP MPS Select Portable Monitor and the DINAMAP MPS Select Multiparameter System. The Advanced NIBP Module is intended to obtain a single patient’s systolic, diastolic and mean arterial blood pressures and pulse rate in the same intended use environment as the DINAMAP MPS Select Family of Monitors: hospital, outpatient surgery and healthcare practitioner facilities. The Advanced NIBP Module optimizes performance in the presence of artifact. The Module combines Advanced NIBP for use with small adult, adult, large adult and thigh cuffs with standard NIBP for use with neonatal cuffs. The device is intended for use by qualified healthcare personnel trained in its use.
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/K982641 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982641: Advanced Nibp Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982641
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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