510(k) · Cleared
ClearedWyntek Osom HCG-Urine Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wyntek Diagnostics, Inc. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Aug 29, 1995 after a 41-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Aug 29, 1995
- Review
- 41 days
- Class
- Class II
- Product code
- JHI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK953383 Wyntek Osom HCG-Urine TestWyntek Diagnostics, Inc. · 1995
- Descendant · cites it directly · 0 of its ownK984076 Instant-View Pregnancy Urine TestAlfa Scientific Designs, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK984079 Instant-View Pregnancy Urine Dip-Strip TestAlfa Scientific Designs, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK962906 Scripps Laboratories HCG One-StepScripps Laboratories, Inc. · 1996
Most influential descendants
Showing 3 of 3 · See all- K984076Instant-View Pregnancy Urine TestAlfa Scientific Designs, Inc. · 1999 · cites it directly0descendants
- K984079Instant-View Pregnancy Urine Dip-Strip TestAlfa Scientific Designs, Inc. · 1999 · cites it directly0descendants
- K962906Scripps Laboratories HCG One-StepScripps Laboratories, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953383 | Wyntek Osom HCG-Urine Test | Wyntek Diagnostics, Inc. | 1995 | — |
| +1 | K984076 | Instant-View Pregnancy Urine Test | Alfa Scientific Designs, Inc. | 1999 | — |
| +1 | K984079 | Instant-View Pregnancy Urine Dip-Strip Test | Alfa Scientific Designs, Inc. | 1999 | — |
| +1 | K962906 | Scripps Laboratories HCG One-Step | Scripps Laboratories, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 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 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
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, K984076 (Alfa Scientific Designs, Inc., 1999) has gone furthest, with 0 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/K953383 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953383: Wyntek Osom HCG-Urine Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953383
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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