510(k) · Cleared
ClearedAccess HTSH Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Cleared on Mar 1, 1993 after a 112-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Mar 1, 1993
- Review
- 112 days
- Class
- Class II
- Product code
- JLW
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK925637 Access HTSH AssayBio-Rad Laboratories, Inc. · 1993
- Descendant · cites it directly · 7 of its ownK023093 Access Hypersensitive HTSH AssayBeckman Coulter, Inc. · 2002
- Descendant · cites it directly · 6 of its ownK042281 Modification to Access Hypersensitive HTSH AssayBeckman Coulter, Inc. · 2004
- Descendant · 2 generations on · 4 of its ownK090588 Power Processor Sample Processing System with Generic Connection…Beckman Coulter, Inc. · 2009
- Descendant · 3 generations on · 3 of its ownK110413 Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc. · 2011 · Recalled
- Descendant · 4 generations on · 1 of its ownK140496 Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate…Beckman Coulter, Inc. · 2014 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K023093Access Hypersensitive HTSH AssayBeckman Coulter, Inc. · 2002 · cites it directly7descendants
- K042281Modification to Access Hypersensitive HTSH AssayBeckman Coulter, Inc. · 2004 · cites it directly6descendants
- K090588Power Processor Sample Processing System with Generic Connection Module, Model: 4210Beckman Coulter, Inc. · 2009 · 2 generations on4descendants
- K110413Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc. · 2011 · 3 generations on3descendants
- K140496Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access…Beckman Coulter, Inc. · 2014 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925637 | Access HTSH Assay | Bio-Rad Laboratories, Inc. | 1993 | — |
| +1 | K023093 | Access Hypersensitive HTSH Assay | Beckman Coulter, Inc. | 2002 | — |
| +1 | K042281 | Modification to Access Hypersensitive HTSH Assay | Beckman Coulter, Inc. | 2004 | — |
| +2 | K090588 | Power Processor Sample Processing System with Generic Connection Module… | Beckman Coulter, Inc. | 2009 | — |
| +3 | K110413 | Power Processor Sample Processing System with Generic Connections | Beckman Coulter, Inc. | 2011 | 2 |
| +4 | K140496 | Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access… | Beckman Coulter, Inc. | 2014 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 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 JLW? 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 JLW device
- #1 K251543 Atellica® IM TSH3-Ultra II (TSH3ULII)score 11.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (8)
2 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, K023093 (Beckman Coulter, Inc., 2002) has gone furthest, with 7 descendants of its own.
How does its category compare?
All JLW devicesJLW Radioimmunoassay, Thyroid-Stimulating Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JLW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JLW
194in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JLW
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JLW
103in 2025
MAUDE reports naming product code JLW, 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 | — | 1 | 19 |
| 2008 | 5 | 143 | 0 | 10 |
| 2009 | 2 | — | 0 | 41 |
| 2010 | 1 | — | 1 | 34 |
| 2011 | 0 | — | 1 | 167 |
| 2012 | 1 | — | 3 | 144 |
| 2013 | 1 | — | 0 | 168 |
| 2014 | 1 | — | 0 | 155 |
| 2015 | 3 | 142 | 0 | 203 |
| 2016 | 3 | 238 | 1 | 183 |
| 2017 | 4 | 194 | 0 | 235 |
| 2018 | 0 | — | 4 | 249 |
| 2019 | 1 | — | 1 | 216 |
| 2020 | 0 | — | 2 | 145 |
| 2021 | 0 | — | 0 | 146 |
| 2022 | 1 | — | 0 | 137 |
| 2023 | 1 | — | 0 | 162 |
| 2024 | 2 | — | 2 | 169 |
| 2025 | 1 | — | 2 | 103 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K925637 · printed Nov 5, 2026
Cite this page
510(k) Report. “K925637: Access HTSH Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K925637
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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