510(k) · Cleared
ClearedABL555 Blood Gas, Electrolyte & Metabolite 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 Oct 6, 1997 as substantially equivalent to K914166 (Radiometer America, Inc., 1992) after a 28-day review. Its family tree reaches back 1 generation to 1992. 46 later devices descend from it.
- Decided
- Oct 6, 1997
- Review
- 28 days
- Class
- Class II
- Product code
- CHL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K914166 (1992). 46 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK914166 ABL505 Blood Gas & Electrolyte SystemRadiometer America, Inc. · 1992 · Recalled
- This deviceK973367 ABL555 Blood Gas, Electrolyte & Metabolite SystemRadiometer America, Inc. · 1997
- Descendant · cites it directly · 44 of its ownK980130 ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite SystemRadiometer America, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 31 of its ownK992859 ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · Recalled
- Descendant · 3 generations on · 29 of its ownK041874 ABL800 FlexRadiometer Medical Aps · 2004 · Recalled
- Descendant · 4 generations on · 18 of its ownK050869 Modification to ABL800 FlexRadiometer Medical Aps · 2005 · Recalled
- Descendant · 2 generations on · 16 of its ownK991417 Abl 735 AnalyzerRadiometer America, Inc. · 1999 · Recalled
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K980130ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite SystemRadiometer America, Inc. · 1998 · cites it directly44descendants
- K992859ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · 2 generations on31descendants
- K041874ABL800 FlexRadiometer Medical Aps · 2004 · 3 generations on29descendants
- K050869Modification to ABL800 FlexRadiometer Medical Aps · 2005 · 4 generations on18descendants
- K991417Abl 735 AnalyzerRadiometer America, Inc. · 1999 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914166 | ABL505 Blood Gas & Electrolyte System | Radiometer America, Inc. | 1992 | 1 |
| 0 (this device) | K973367 | ABL555 Blood Gas, Electrolyte & Metabolite System | Radiometer America, Inc. | 1997 | — |
| +1 | K980130 | ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite System | Radiometer America, Inc. | 1998 | 5 |
| +2 | K992859 | ABL700 Series Analyzer with Autocheck Module | Radiometer America, Inc. | 2000 | 4 |
| +3 | K041874 | ABL800 Flex | Radiometer Medical Aps | 2004 | 22 |
| +4 | K050869 | Modification to ABL800 Flex | Radiometer Medical Aps | 2005 | 1 |
| +2 | K991417 | Abl 735 Analyzer | Radiometer America, Inc. | 1999 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 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? (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 |
|---|---|---|---|
| * | K914166 | ABL505 Blood Gas & Electrolyte SystemSummary page 1…ersion ABL505. SUBSTANTIAL EQUIVALENCE: ABLS5S5S is substantially equivalent in features and characteristics to the current ABL505 marketed by Radiometer America Inc. (K914166). The major difference is the addition of the glucose analyte and the elimination of the Ca™and CI electrodes. ¥… | 1992 |
| * | — | EML105 Named without a submission number |
What descends from it? (46)
See all 462 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has a recall.
- Of its descendants, K980130 (Radiometer America, Inc., 1998) has gone furthest, with 44 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?
ABLSSS is a stand alone, blood gas, electrolyte and metabolite analyzer that measures pH,
O,, pO,, Na*, K*, and glucose on whole blood.
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/K973367 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973367: ABL555 Blood Gas, Electrolyte & Metabolite System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973367
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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