510(k) · Cleared
ClearedAccess Ultrasensitive HGH Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JIT Calibrator, Secondary
Cleared on Nov 20, 2000 after a 48-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Nov 20, 2000
- Review
- 48 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK003098 Access Ultrasensitive HGH CalibratorsBeckman Coulter, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK040181 Access Dhea-S Reagent AssayBeckman Coulter, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK111762 ST Aia-Pack Dhea-S Calibrator SetTosoh Bioscience, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK061282 Access Ultrasensitive HGH Calibrator, Model 33585Beckman Coulter, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK042651 Free T3 Calibrators on the Access Immunoassay SystemsBeckman Coulter, Inc. · 2004 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K040181Access Dhea-S Reagent AssayBeckman Coulter, Inc. · 2004 · cites it directly1descendant
- K111762ST Aia-Pack Dhea-S Calibrator SetTosoh Bioscience, Inc. · 2011 · 2 generations on0descendants
- K061282Access Ultrasensitive HGH Calibrator, Model 33585Beckman Coulter, Inc. · 2006 · cites it directly0descendants
- K042651Free T3 Calibrators on the Access Immunoassay SystemsBeckman Coulter, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003098 | Access Ultrasensitive HGH Calibrators | Beckman Coulter, Inc. | 2000 | — |
| +1 | K040181 | Access Dhea-S Reagent Assay | Beckman Coulter, Inc. | 2004 | — |
| +2 | K111762 | ST Aia-Pack Dhea-S Calibrator Set | Tosoh Bioscience, Inc. | 2011 | — |
| +1 | K061282 | Access Ultrasensitive HGH Calibrator, Model 33585 | Beckman Coulter, Inc. | 2006 | — |
| +1 | K042651 | Free T3 Calibrators on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2011 | 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 JIT? 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040181 (Beckman Coulter, Inc., 2004) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, 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 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K003098 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003098: Access Ultrasensitive HGH Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003098
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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