510(k) · Cleared
Recalled · 2011ABL505 Blood Gas & Electrolyte 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 28, 1992 after a 133-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 47 later devices descend from it. It has been recalled once.
- Decided
- Jan 28, 1992
- Review
- 133 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 1
- Predicates
- 0
47 later devices descend from it, 1 citing it directly.
- This deviceK914166 ABL505 Blood Gas & Electrolyte SystemRadiometer America, Inc. · 1992
- Descendant · cites it directly · 46 of its ownK973367 ABL555 Blood Gas, Electrolyte & Metabolite SystemRadiometer America, Inc. · 1997
- Descendant · 2 generations on · 44 of its ownK980130 ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite SystemRadiometer America, Inc. · 1998 · Recalled
- Descendant · 3 generations on · 31 of its ownK992859 ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · Recalled
- Descendant · 4 generations on · 29 of its ownK041874 ABL800 FlexRadiometer Medical Aps · 2004 · Recalled
- Descendant · 5 generations on · 18 of its ownK050869 Modification to ABL800 FlexRadiometer Medical Aps · 2005 · Recalled
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K973367ABL555 Blood Gas, Electrolyte & Metabolite SystemRadiometer America, Inc. · 1997 · cites it directly46descendants
- K980130ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite SystemRadiometer America, Inc. · 1998 · 2 generations on44descendants
- K992859ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · 3 generations on31descendants
- K041874ABL800 FlexRadiometer Medical Aps · 2004 · 4 generations on29descendants
- K050869Modification to ABL800 FlexRadiometer Medical Aps · 2005 · 5 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914166 | ABL505 Blood Gas & Electrolyte System | Radiometer America, Inc. | 1992 | — |
| +1 | K973367 | ABL555 Blood Gas, Electrolyte & Metabolite System | Radiometer America, Inc. | 1997 | — |
| +2 | K980130 | ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite System | Radiometer America, Inc. | 1998 | 5 |
| +3 | K992859 | ABL700 Series Analyzer with Autocheck Module | Radiometer America, Inc. | 2000 | 4 |
| +4 | K041874 | ABL800 Flex | Radiometer Medical Aps | 2004 | 22 |
| +5 | K050869 | Modification to ABL800 Flex | Radiometer Medical Aps | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 14.2 · 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (47)
See all 471 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973367 | ABL555 Blood Gas, Electrolyte & Metabolite System | 1997 | 46 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 7, 2011 | Not classified | Z-2571-2011 | Pending | Based on internal testing and user/customer complaint reports received, the firm determined that wrinkles may arise on the outer membrane of the calcium membrane units upon installation. Retention of fluids between the wrinkles can cause… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K973367 (Radiometer America, Inc., 1997) has gone furthest, with 46 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 | — |
https://510kreport.com/device/K914166 · printed Nov 4, 2026
Cite this page
510(k) Report. “K914166: ABL505 Blood Gas & Electrolyte System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K914166
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026