510(k) · Cleared
Recalled · Class II · 2017Emit (R) 2000 Theophylline Assay/Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syva Co. · KLS Enzyme Immunoassay, Theophylline
Cleared on Sep 19, 1991 after a 66-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Sep 19, 1991
- Review
- 66 days
- Class
- Class II
- Product code
- KLS
- Recalls
- 3
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK913123 Emit (R) 2000 Theophylline Assay/CalibratorsSyva Co. · 1991
- Descendant · cites it directly · 0 of its ownK993029 Abbott Aeroset Theophylline Assay and Calibrators; Models 1E09 and…Syva Co. · 2000
Most influential descendants
Showing 1 of 1 · See all- K993029Abbott Aeroset Theophylline Assay and Calibrators; Models 1E09 and 6E89Syva Co. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913123 | Emit (R) 2000 Theophylline Assay/Calibrators | Syva Co. | 1991 | — |
| +1 | K993029 | Abbott Aeroset Theophylline Assay and Calibrators; Models 1E09 and 6E89 | Syva Co. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 KLS? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993029 | Abbott Aeroset Theophylline Assay and Calibrators; Models 1E09 and 6E89 | 2000 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 27, 2017 | Class II | Z-1946-2018 | Nonconforming Material/Component | Lot J1 of the Syva¿ EMIT¿ 2000 Theophylline Assay, when run on a Beckman AU Clinical Chemistry System, may exhibit increased imprecision for commercially available controls and for patient samples. |
| Jun 17, 2016 | Class II | Z-2298-2016 | Process control | Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the ADVIA¿ Chemistry Theophylline_2 (THEO_2) reagent lot 334018, may exhibit increased… |
| Jun 17, 2016 | Class II | Z-2299-2016 | Process control | Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the ADVIA¿ Chemistry Theophylline_2 (THEO_2) reagent lot 334018, may exhibit increased… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K993029 (Syva Co., 2000) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KLS devicesKLS Enzyme Immunoassay, Theophylline: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLS
FDA has decided no KLS device since 2007.
Median 510(k) review, days · KLS
Too few KLS 510(k)s in any year since 2007 to give a median.
Recalls per year · KLS
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLS
1in 2025
MAUDE reports naming product code KLS, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 2 | 0 |
| 2013 | 0 | — | 2 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K913123 · printed Nov 6, 2026
Cite this page
510(k) Report. “K913123: Emit (R) 2000 Theophylline Assay/Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913123
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026