510(k) · Cleared
Recalled · 2005Abl 735 Analyzer
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 Nov 24, 1999 as substantially equivalent to K980130 (Radiometer America, Inc., 1998) and 3 other predicates after a 215-day review. Its family tree reaches back 3 generations to 1995. 16 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 24, 1999
- Review
- 215 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 3 generations to K952621 (1995). 8 ancestors in all, the oldest K790608 (1979). 16 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK952621 EML105 Electrolyte Metabolite AnalyzerRadiometer America, Inc. · 1995
- 2 generations backK962334 EML105 Electrolyte Metabolite AnalyzerRadiometer America, Inc. · 1996 · Recalled
- 1 generation backK980130 ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite SystemRadiometer America, Inc. · 1998 · Recalled
- This deviceK991417 Abl 735 AnalyzerRadiometer America, Inc. · 1999
- Descendant · cites it directly · 12 of its ownK093623 Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter)…Instrumentation Laboratory CO · 2010 · Recalled
- Descendant · 2 generations on · 11 of its ownK112995 Gem Premier 4000Instrumentation Laboratory CO · 2012
- Descendant · 3 generations on · 10 of its ownK133407 Gem Premier 4000Instrumentation Laboratory CO · 2014
- Descendant · 4 generations on · 2 of its ownK173403 GEM Premier 5000Instrumentation Laboratory CO · 2017
- Descendant · 2 generations on · 2 of its ownK160225 GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride…Instrumentation Laboratory CO · 2016
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K093623Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2 (Addition…Instrumentation Laboratory CO · 2010 · cites it directly12descendants
- K112995Gem Premier 4000Instrumentation Laboratory CO · 2012 · 2 generations on11descendants
- K133407Gem Premier 4000Instrumentation Laboratory CO · 2014 · 3 generations on10descendants
- K173403GEM Premier 5000Instrumentation Laboratory CO · 2017 · 4 generations on2descendants
- K160225GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM…Instrumentation Laboratory CO · 2016 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952621 | EML105 Electrolyte Metabolite Analyzer | Radiometer America, Inc. | 1995 | — |
| −2 | K962334 | EML105 Electrolyte Metabolite Analyzer | Radiometer America, Inc. | 1996 | 1 |
| −1 | K980130 | ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite System | Radiometer America, Inc. | 1998 | 5 |
| 0 (this device) | K991417 | Abl 735 Analyzer | Radiometer America, Inc. | 1999 | — |
| +1 | K093623 | Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2… | Instrumentation Laboratory CO | 2010 | 5 |
| +2 | K112995 | Gem Premier 4000 | Instrumentation Laboratory CO | 2012 | — |
| +3 | K133407 | Gem Premier 4000 | Instrumentation Laboratory CO | 2014 | — |
| +4 | K173403 | GEM Premier 5000 | Instrumentation Laboratory CO | 2017 | — |
| +2 | K160225 | GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized… | Instrumentation Laboratory CO | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 1 | 0 |
| 1992 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 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 14.1 · 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? (5)
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 |
|---|---|---|---|
| * | K980130 | ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite SystemSummary page 1…BL735 Common Name: pH/Blood Gas/Co-oximetry/Electrolyte/Metabolyte Analyzer Classification Name: Blood Gas and Blood pH Test System PREDICATE DEVICE: Radiometer ABL700 (K980130), for neonate bilirubin testing the Unistat (Leica Inc., K922770) and the Advanced Bilirubin Stat Analyzer Model BR2 (Advanced In… | 1998 |
| * | K922770 | Unistat Bilirubinometer Models 10310 and 10311Summary page 1…e Analyzer Classification Name: Blood Gas and Blood pH Test System PREDICATE DEVICE: Radiometer ABL700 (K980130), for neonate bilirubin testing the Unistat (Leica Inc., K922770) and the Advanced Bilirubin Stat Analyzer Model BR2 (Advanced Instruments Inc., K790608) and for adult bilirubin testing the Vitr… | 1992 |
| * | K790608 | BL BilirubinometerSummary page 1…diometer ABL700 (K980130), for neonate bilirubin testing the Unistat (Leica Inc., K922770) and the Advanced Bilirubin Stat Analyzer Model BR2 (Advanced Instruments Inc., K790608) and for adult bilirubin testing the Vitros (Johnson and Johnson Clinical Diagnostics, formerly Kodak Clinical Diagnostics, K3406… | 1979 |
| Kept off the family tree | K340606 | Vitros Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…Model BR2 (Advanced Instruments Inc., K790608) and for adult bilirubin testing the Vitros (Johnson and Johnson Clinical Diagnostics, formerly Kodak Clinical Diagnostics, K340606; K840880). PRODUCT DESCRIPTION: ABL73S is an automated pH/Blood Gas/Co-oximetry/Electrolyte/Metabo- lyte Analyzer that is 44cm… | |
| * | K840880 | Ektachem Clinical Chem. SlidesSummary page 1…(Advanced Instruments Inc., K790608) and for adult bilirubin testing the Vitros (Johnson and Johnson Clinical Diagnostics, formerly Kodak Clinical Diagnostics, K340606; K840880). PRODUCT DESCRIPTION: ABL73S is an automated pH/Blood Gas/Co-oximetry/Electrolyte/Metabo- lyte Analyzer that is 44cm X 70cm X… | 1984 |
What descends from it? (16)
See all 163 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 29, 2005 | Not classified | Z-1386-06 | Other | Under certain circumstances, the ABL 700 & 800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers intermittently provide incorrect (too low) result values for Calcium (Ca) and… |
| Jun 17, 2005 | Not classified | Z-1317-06 | Other | Software defect. pO2 and pCO2 sample test results run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 1.3 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K093623 (Instrumentation Laboratory CO, 2010) has gone furthest, with 12 descendants of its own.
- 3 other devices also cite its predicate K980130.
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?
The ABL735 is intended for in vitro testing of samples of whole blood for the parameters pH,p02,.pCO02, potassium, sodium, calcium, chloride, glucose, 1actate, total bilirubin, and coOoximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions f02Hb, fCOHb fMetHb fHHD, and fHbLF)
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/K991417 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991417: Abl 735 Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991417
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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