510(k) · Cleared
Recalled · Class II · 2019Aeroset System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · CGZ Electrode, Ion-Specific, Chloride
Cleared on Apr 1, 1998 as substantially equivalent to K872494 (Boehringer Mannheim Corp., 1987) after a 62-day review. Its family tree reaches back 1 generation to 1987. 7 later devices descend from it. It has been recalled 34 times.
- Decided
- Apr 1, 1998
- Review
- 62 days
- Class
- Class II
- Product code
- CGZ
- Recalls
- 34
- Predicates
- 1
Its longest line of descent runs back 1 generation to K872494 (1987). 7 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK872494 Hitachi 717 Chemistry AnalyzerBoehringer Mannheim Corp. · 1987
- This deviceK980367 Aeroset SystemAbbott Laboratories · 1998
- Descendant · cites it directly · 3 of its ownK093318 Accelerator ApsAbbott Laboratories · 2010 · Recalled
- Descendant · 2 generations on · 1 of its ownK213486 GLP systems TrackAbbott Laboratories · 2022
- Descendant · cites it directly · 1 of its ownK170320 Alinity c ICT Sample DiluentAbbott Laboratories · 2017
- Descendant · cites it directly · 1 of its ownK170316 Alinity C Glucose Reagent Kit, Alinity C SystemAbbott Laboratories · 2017 · Recalled
- Descendant · 3 generations on · 0 of its ownK230937 Alinity i Total ß-hCG Reagent Kit, GLP systems TrackAbbott Laboratories · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K093318Accelerator ApsAbbott Laboratories · 2010 · cites it directly3descendants
- K213486GLP systems TrackAbbott Laboratories · 2022 · 2 generations on1descendant
- K170320Alinity c ICT Sample DiluentAbbott Laboratories · 2017 · cites it directly1descendant
- K170316Alinity C Glucose Reagent Kit, Alinity C SystemAbbott Laboratories · 2017 · cites it directly1descendant
- K230937Alinity i Total ß-hCG Reagent Kit, GLP systems TrackAbbott Laboratories · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872494 | Hitachi 717 Chemistry Analyzer | Boehringer Mannheim Corp. | 1987 | — |
| 0 (this device) | K980367 | Aeroset System | Abbott Laboratories | 1998 | — |
| +1 | K093318 | Accelerator Aps | Abbott Laboratories | 2010 | 2 |
| +2 | K213486 | GLP systems Track | Abbott Laboratories | 2022 | — |
| +1 | K170320 | Alinity c ICT Sample Diluent | Abbott Laboratories | 2017 | — |
| +1 | K170316 | Alinity C Glucose Reagent Kit, Alinity C System | Abbott Laboratories | 2017 | 1 |
| +3 | K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | Abbott Laboratories | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 2 | 0 |
| 2022 | 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 CGZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K872494 | Hitachi 717 Chemistry AnalyzerSummary page 3…stantial Equivalence: Substantial equivalence has been demonstrated between the AEROSET System and the Boehringer Mannheim Diagnostics' Hitachi® 717 Chemistry Analyzer (K872494). Both systems utilize monochromatic and bichromatic spectrophotometry to perform quantitative kinetic and endpoint clinical che… | 1987 |
What descends from it? (7)
3 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 |
|---|---|---|---|---|
| May 1, 2019 | Class II | Z-1671-2020 | Device Design | Mixer blade may separate from mixer due to the screw and nut failure and detachment. As a result of the mixer blade missing, the sample and reagent are inadequately mixed. |
| Aug 28, 2018 | Class II | Z-1296-2019 | Under Investigation by firm | There is a potential to generate falsely elevated serum or plasma chloride results when using the product. |
| Jul 17, 2018 | Class II | Z-1102-2019 | Software design | There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status. |
| Jul 17, 2018 | Class II | Z-1104-2019 | Software design | There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status. |
| Jul 17, 2018 | Class II | Z-1103-2019 | Software design | There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status. |
| Dec 8, 2017 | Class II | Z-0922-2018 | Device Design | There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument. |
| Dec 8, 2017 | Class II | Z-0921-2018 | Device Design | There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument. |
| Dec 8, 2017 | Class II | Z-0923-2018 | Device Design | There is a potential to generate falsely depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000, c8000, and c16000 instrument. |
| Sep 29, 2017 | Class II | Z-0165-2018 | Component design/selection | The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector. |
| Sep 29, 2017 | Class II | Z-0166-2018 | Component design/selection | The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector. |
| Sep 9, 2015 | Class II | Z-0163-2016 | Nonconforming Material/Component | Incorrect tubing. |
| Jun 11, 2015 | Class II | Z-2202-2015 | Mixed-up of materials/components | The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak. |
| May 11, 2015 | Class II | Z-1725-2015 | Under Investigation by firm | The product is leaking from the cap and crystallization was noted as present around the cap. |
| Jan 15, 2015 | Class II | Z-0011-2018 | Device Design | There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the c4000 instrument. |
| Jul 22, 2014 | Class II | Z-1932-2015 | Process control | ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on the Abbott Architect cSystem. |
| May 23, 2008 | Not classified | Z-2231-2008 | Software design | Software defect can allow tests ordered for one sample to be aspirated from a different sample, reporting erroneous results for the affected sample. |
| Sep 26, 2007 | Not classified | Z-1166-2008 | Component design/selection | Quality Control (Out of Range)- ICT Calibrator lot number: 0505017, may contain an interferent. Not all vials within a kit are affected. The investigation determined that the interferent affects Potassium (K+) only. Use of the affected… |
| Sep 5, 2007 | Not classified | Z-0146-2008 | Software change control | Incorrect Sample/Test Identification: Due to a software timing defect with certain versions of ARCHITECT cSystem Software, test results may be incorrectly associated to a Sample Identification during specific sample-processing conditions… |
| Apr 30, 2007 | Not classified | Z-0952-2007 | Other | One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline math model. 2) The system configuration option, Run controls onboard reagents by Kit, does not function correctly for assays… |
| Dec 8, 2005 | Not classified | Z-0398-06 | Other | System software assigns a calibrator default volume of 2.0uL when field is left empty by operator at time assay parameters set. Patient results could be affected if the volume required is not 2.0 uL. |
| Sep 14, 2005 | Not classified | Z-0010-06 | Other | Software deficiency causing potential shift in absorbance readings for test results. |
| Feb 28, 2005 | Not classified | Z-0008-06 | Other | Device has incorrect notation associated with therapeutic drug monitoring assays. |
| Sep 24, 2004 | Not classified | Z-0016-05 | Other | Changes to the printer default settings made by users/operators cause printed data to be truncated and misidentified. |
| Jun 10, 2004 | Not classified | Z-1341-04 | Other | Process change in the manufacturing of the AC/DC driver board used on the analyzer may result in one or more of the solid state relays to fail during use. |
| Mar 22, 2004 | Not classified | Z-0846-04 | Other | Change of level 3 error log messages to level 1 to prevent suspect assay results. |
| Mar 19, 2004 | Not classified | Z-0818-04 | Other | When using a LIS the software system will send up a test result of up to 20 characters although the field is set to display only 15 characters per the RS-232 Manual. |
| Nov 17, 2003 | Not classified | Z-0263-04 | Other | Sample Identification (SID) numbers of a bar coded sample may be truncated, or shortened, after being scanned by the bar code reader (e.g. an actual SID of 123456 is shortened to 1234) |
| Sep 30, 2003 | Not classified | Z-0091-04 | Other | Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples. |
| Feb 24, 2003 | Not classified | Z-0725-03 | Other | Under certain operating conditions, smart wash feature disables with multiple samples. |
| Feb 24, 2003 | Not classified | Z-0788-03 | Other | Software failure to detect error in reference solution set-up can cause inaccurate results for Sodium, Potassium, and Chloride. |
| Jan 27, 2003 | Not classified | Z-0796-03 | Other | External waste pump has metal edge around perimeter sharp enough to cause scratch or cut. |
| Aug 15, 2002 | Not classified | Z-0844-03 | Other | Design of high concentration waste line causes formation of a precipitate in the waste line causing overflow of waste. |
| Oct 2, 2001 | Not classified | Z-0843-03 | Other | Extensive use of cuvettes causes inaccurate results. Preventative maintenance did not specify replacement schedule. |
| Dec 29, 2000 | Not classified | Z-1142-03 | Other | ICT assays run using a manual dilution will not be calculated correctly by the software. |
The 5 latest of 34 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All CGZ devicesCGZ Electrode, Ion-Specific, Chloride: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGZ
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · CGZ
Too few CGZ 510(k)s in any year since 2007 to give a median.
Recalls per year · CGZ
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGZ
5in 2025
MAUDE reports naming product code CGZ, 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 | — | 1 | 4 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 5 |
| 2012 | 0 | — | 0 | 30 |
| 2013 | 0 | — | 0 | 42 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 19 |
| 2019 | 0 | — | 2 | 3 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Per 21 CFR 862.2160, the AEROSET System is a discrete photometric chemistry Analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. The AEROSET System also has a solid state Ion-Selective Electrode module, trademarked as Integrated Chip Technology™ (ICT), utilizing potentiometry, for electrolyte determinations (sodium, potassium, and chloride).
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/K980367 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980367: Aeroset System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980367
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