510(k) · Cleared
ClearedCiba Corning Acs HCG Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ciba Corning Diagnostics Corp. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Mar 19, 1993 after a 150-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Mar 19, 1993
- Review
- 150 days
- Class
- Class II
- Product code
- JHI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK925277 Ciba Corning Acs HCG ImmunoassayCiba Corning Diagnostics Corp. · 1993
- Descendant · cites it directly · 2 of its ownK172322 Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK130020 Access Total BHCG (5TH IS)Beckman Coulter, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK221990 Access Total ßhCG (5th IS)Beckman Coulter, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK200210 ADVIA Centaur® Total hCG assaySiemens Healthcare Diagnostics, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK192547 Maglumi 2000 HCG/ß-HCGShenzhen New Industries Biomedical Engineering Co., Ltd. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc. · 2018 · cites it directly2descendants
- K130020Access Total BHCG (5TH IS)Beckman Coulter, Inc. · 2013 · cites it directly2descendants
- K221990Access Total ßhCG (5th IS)Beckman Coulter, Inc. · 2022 · 2 generations on0descendants
- K200210ADVIA Centaur® Total hCG assaySiemens Healthcare Diagnostics, Inc. · 2021 · 2 generations on0descendants
- K192547Maglumi 2000 HCG/ß-HCGShenzhen New Industries Biomedical Engineering Co., Ltd. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925277 | Ciba Corning Acs HCG Immunoassay | Ciba Corning Diagnostics Corp. | 1993 | — |
| +1 | K172322 | Atellica IM Total hCG (ThCG) | Siemens Healthcare Diagnostics, Inc. | 2018 | — |
| +1 | K130020 | Access Total BHCG (5TH IS) | Beckman Coulter, Inc. | 2013 | — |
| +2 | K221990 | Access Total ßhCG (5th IS) | Beckman Coulter, Inc. | 2022 | — |
| +2 | K200210 | ADVIA Centaur® Total hCG assay | Siemens Healthcare Diagnostics, Inc. | 2021 | — |
| +2 | K192547 | Maglumi 2000 HCG/ß-HCG | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 JHI? 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 JHI device
- #1 K262299 Instant-View® hCG Combo II Cassette Testscore 12.7 · 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
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, K172322 (Siemens Healthcare Diagnostics, Inc., 2018) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JHI devicesJHI Visual, Pregnancy Hcg, Prescription Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JHI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JHI
101in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JHI
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHI
265in 2025
MAUDE reports naming product code JHI, 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 | 4 | 101 | 6 | 245 |
| 2008 | 0 | — | 8 | 29 |
| 2009 | 0 | — | 1 | 106 |
| 2010 | 1 | — | 2 | 143 |
| 2011 | 0 | — | 1 | 138 |
| 2012 | 2 | — | 0 | 219 |
| 2013 | 2 | — | 0 | 185 |
| 2014 | 2 | — | 0 | 112 |
| 2015 | 0 | — | 0 | 134 |
| 2016 | 1 | — | 0 | 143 |
| 2017 | 1 | — | 0 | 113 |
| 2018 | 1 | — | 0 | 132 |
| 2019 | 0 | — | 0 | 571 |
| 2020 | 0 | — | 0 | 114 |
| 2021 | 0 | — | 0 | 158 |
| 2022 | 1 | — | 0 | 126 |
| 2023 | 0 | — | 6 | 147 |
| 2024 | 1 | — | 1 | 256 |
| 2025 | 0 | — | 0 | 265 |
| 2026 | 1 | — | 4 | — |
https://510kreport.com/device/K925277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925277: Ciba Corning Acs HCG Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925277
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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