510(k) · Cleared
Recalled · 2006NPT7 Series PH/Blood Gas and CO-Oximetry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiometer America, Inc. · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Jan 6, 1999 after a 139-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 13 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 6, 1999
- Review
- 139 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 2
- Predicates
- 0
13 later devices descend from it, 1 citing it directly.
- This deviceK982928 NPT7 Series PH/Blood Gas and CO-Oximetry SystemRadiometer America, Inc. · 1999
- Descendant · cites it directly · 12 of its ownK092686 ABL90 Flex SeriesRadiometer Medical Aps · 2010 · Recalled
- Descendant · 2 generations on · 6 of its ownK120197 ABL90 FlexRadiometer Medical Aps · 2012 · Recalled
- Descendant · 3 generations on · 5 of its ownK122729 ABL90 FlexRadiometer Medical Aps · 2012
- Descendant · 4 generations on · 3 of its ownK131988 ABL90 Flex AnalyzerRadiometer Medical Aps · 2013
- Descendant · 5 generations on · 2 of its ownK160153 ABL90 Flex PlusRadiometer Medical Aps · 2016 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K092686ABL90 Flex SeriesRadiometer Medical Aps · 2010 · cites it directly12descendants
- K120197ABL90 FlexRadiometer Medical Aps · 2012 · 2 generations on6descendants
- K122729ABL90 FlexRadiometer Medical Aps · 2012 · 3 generations on5descendants
- K131988ABL90 Flex AnalyzerRadiometer Medical Aps · 2013 · 4 generations on3descendants
- K160153ABL90 Flex PlusRadiometer Medical Aps · 2016 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982928 | NPT7 Series PH/Blood Gas and CO-Oximetry System | Radiometer America, Inc. | 1999 | — |
| +1 | K092686 | ABL90 Flex Series | Radiometer Medical Aps | 2010 | 10 |
| +2 | K120197 | ABL90 Flex | Radiometer Medical Aps | 2012 | 3 |
| +3 | K122729 | ABL90 Flex | Radiometer Medical Aps | 2012 | — |
| +4 | K131988 | ABL90 Flex Analyzer | Radiometer Medical Aps | 2013 | — |
| +5 | K160153 | ABL90 Flex Plus | Radiometer Medical Aps | 2016 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CHL? 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 CHL device
- #1 K252207 ABL90 FLEX PLUS System, safeCLINITUBESscore 14.1 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092686 | ABL90 Flex Series | 2010 | 12 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 1, 2006 | Not classified | Z-1261-06 | Other | Air bubbles may be trapped on or close to the O2 sensor in the pO2 chamber of the cuvettes in cartridges used for blood gas analysis on NPT7 analyzer. This produces too high pO2 readings without a question mark. |
| Jan 12, 2005 | Not classified | Z-1406-06 | Other | QC Bias-a solution used in the manufacturing of the membrane had a different composition which introduces a bias of 20 mpH. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K092686 (Radiometer Medical Aps, 2010) has gone furthest, with 12 descendants of its own.
How does its category compare?
All CHL devicesCHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CHL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHL
267in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHL
13so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHL
210in 2025
MAUDE reports naming product code CHL, 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 | 1 | — | 6 | 16 |
| 2008 | 1 | — | 5 | 40 |
| 2009 | 0 | — | 6 | 74 |
| 2010 | 1 | — | 7 | 20 |
| 2011 | 4 | 108 | 1 | 50 |
| 2012 | 4 | 65 | 9 | 64 |
| 2013 | 5 | 152 | 1 | 62 |
| 2014 | 3 | 68 | 1 | 93 |
| 2015 | 4 | 155 | 3 | 55 |
| 2016 | 3 | 306 | 1 | 118 |
| 2017 | 1 | — | 1 | 206 |
| 2018 | 1 | — | 3 | 174 |
| 2019 | 0 | — | 0 | 141 |
| 2020 | 4 | 100 | 2 | 117 |
| 2021 | 2 | — | 0 | 147 |
| 2022 | 0 | — | 0 | 138 |
| 2023 | 5 | 267 | 4 | 177 |
| 2024 | 1 | — | 9 | 196 |
| 2025 | 1 | — | 0 | 210 |
| 2026 | 1 | — | 13 | — |
What is it indicated for?
NPT7 Series is a stand-alone blood gas analyzer that measures pH, pCO, pO, ,and Co-oximetry parameters on human arterial/venous and capillary whole blood. The NPT7 Near Patient Testing System in its various configurations is intended for use in laboratory and point-of-care testing of pH, blood gases and co-oximetry parameters on whole blood samples by minimally trained personnel. The device is designed for stationary use as well as use in moving vehicles and air crafts.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982928 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982928: NPT7 Series PH/Blood Gas and CO-Oximetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982928
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