510(k) · Cleared
Recalled · 2003Nibp and CO2 Options for the Physio-Control Lifepak 12 Defibrillator/Monitor System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Physio-Control Corp. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Sep 1, 1999 as substantially equivalent to K982135 (Cas Medical Systems, Inc., 1998) and 2 other predicates after a 210-day review. Its family tree reaches back 1 generation to 1992. 2 of the 16 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it. It has been recalled once.
- Decided
- Sep 1, 1999
- Review
- 210 days
- Class
- Class II
- Product code
- DXN
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 1 generation to K914838 (1992). 3 ancestors in all. 12 later devices descend from it, 6 citing it directly. 2 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK914838 Propaq 102,104,106,102EL,104EL,&106ELProtocol Systems, Inc. · 1992
- This deviceK990338 Nibp and CO2 Options for the Physio-Control Lifepak 12…Physio-Control Corp. · 1999
- Descendant · cites it directly · 10 of its ownK040775 Lifepak 12Medtronic Physio-Control Corp. · 2004 · Recalled
- Descendant · cites it directly · 9 of its ownK041459 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2004
- Descendant · cites it directly · 7 of its ownK063510 Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2007 · Recalled
- Descendant · cites it directly · 5 of its ownK082937 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 4 of its ownK103567 Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2011
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 12 · See all- K040775Lifepak 12Medtronic Physio-Control Corp. · 2004 · cites it directly10descendants
- K041459Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2004 · cites it directly9descendants
- K063510Lifepak 12 Defibrillator/MonitorMedtronic Emergency Response Systems, Inc. · 2007 · cites it directly7descendants
- K082937Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2009 · cites it directly5descendants
- K103567Lifepak 15 Monitor/DefibrillatorPhysio-Control, Inc. · 2011 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914838 | Propaq 102,104,106,102EL,104EL,&106EL | Protocol Systems, Inc. | 1992 | — |
| 0 (this device) | K990338 | Nibp and CO2 Options for the Physio-Control Lifepak 12 Defibrillator/Monitor… | Physio-Control Corp. | 1999 | — |
| +1 | K040775 | Lifepak 12 | Medtronic Physio-Control Corp. | 2004 | 1 |
| +1 | K041459 | Lifepak 12 Defibrillator/Monitor | Medtronic Emergency Response Systems, Inc. | 2004 | — |
| +1 | K063510 | Lifepak 12 Defibrillator/Monitor | Medtronic Emergency Response Systems, Inc. | 2007 | 2 |
| +1 | K082937 | Lifepak 15 Monitor/Defibrillator | Physio-Control, Inc. | 2009 | 3 |
| +2 | K103567 | Lifepak 15 Monitor/Defibrillator | Physio-Control, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 1 |
| 2014 | 1 | 1 |
| 2024 | 1 | 0 |
| 2025 | 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.
2 devices in this family have a Class I recall. 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K982135 | Oscillomate Ems Nibp Monitor Model 9001Summary page 1…The Non-invasive blood pressure (NIBP) monitor portion of this 510(k) submission is substantially equivalent to Oscillomate EMS NIBP Monitor Model 9001 (510[k] reference K982135) and the PROPAQ Models 102, 104, 106, (510[k] reference K914838). All devices non-invasively measure the blood pressure of adult… | 1998 |
| * | K914838 | Propaq 102,104,106,102EL,104EL,&106ELSummary page 1…10(k) submission is substantially equivalent to Oscillomate EMS NIBP Monitor Model 9001 (510[k] reference K982135) and the PROPAQ Models 102, 104, 106, (510[k] reference K914838). All devices non-invasively measure the blood pressure of adult and pediatric patients primarily in the emergency care environme… | 1992 |
| * | K981114 | MicrocapSummary page 1…primarily in the emergency care environment. The Carbon-Dioxide Gas Analyzer portion of this 510(k) submission is substantially equivalent to MICROCAP (510[k] reference K981114) and NPB-75 (510(k] reference K964239). All devices non-invasively measure the carbon dioxide concentration of the expired and in… | 1998 |
| Kept off the family tree | K964239 | FDA’s K964239 is Combination Oximeter/Carbon Dioxide Gas Analyzer Our OCR of the scanned summary read K964239, FDA’s number for Combination Oximeter/Carbon Dioxide Gas Analyzer (Spegas Industries, Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “NPB-75”. Kept off the family tree. Summary page 1…nment. The Carbon-Dioxide Gas Analyzer portion of this 510(k) submission is substantially equivalent to MICROCAP (510[k] reference K981114) and NPB-75 (510(k] reference K964239). All devices non-invasively measure the carbon dioxide concentration of the expired and inspired breath and respiration rate. =… | 1997 |
What descends from it? (12)
See all 126 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 27, 2003 | Not classified | Z-0542-03 | Other | Impact and damage to the high voltage connectors results in poor or no electrical contact from the cable to the LIFEPAK 12 unit. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K130454Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorPhysio-Control, Inc. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
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 LIFEPAK®12 NIBP monitor non-invasively measures blood pressure of the adult and pediatric patients by professionally trained health care providers. It is not designed for continuous, unsupervised monitoring.
The use of the LIFEPAK®12 EtCO2 monitor is indicated whenever professionally trained health care providers determine that a patient requires the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate.
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/K990338 · printed Nov 3, 2026
Cite this page
510(k) Report. “K990338: Nibp and CO2 Options for the Physio-Control Lifepak 12 Defibrillator/Monitor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K990338
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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