510(k) · Cleared
ClearedSas One Step Pregnancy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sa Scientific, Inc. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Feb 2, 1993 after a 55-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Feb 2, 1993
- Review
- 55 days
- Class
- Class II
- Product code
- JHI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK926204 Sas One Step PregnancySa Scientific, Inc. · 1993
- Descendant · cites it directly · 4 of its ownK983090 Acon Midstream Pregnancy TestACON Laboratories, Inc. · 1998
- Descendant · 2 generations on · 0 of its ownK050546 Acon +/- Midstream Pregnancy TestACON Laboratories, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK042151 Acon Spectrum HCG Midstream Pregnancy TestACON Laboratories, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK032510 Acon Quik-Check II Midstream Home Pregnancy TestACON Laboratories, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK023037 Mid Stream Pregnancy TestAdvanced Diagnostics, Inc. · 2003
Most influential descendants
Showing 5 of 5 · See all- K983090Acon Midstream Pregnancy TestACON Laboratories, Inc. · 1998 · cites it directly4descendants
- K050546Acon +/- Midstream Pregnancy TestACON Laboratories, Inc. · 2005 · 2 generations on0descendants
- K042151Acon Spectrum HCG Midstream Pregnancy TestACON Laboratories, Inc. · 2004 · 2 generations on0descendants
- K032510Acon Quik-Check II Midstream Home Pregnancy TestACON Laboratories, Inc. · 2003 · 2 generations on0descendants
- K023037Mid Stream Pregnancy TestAdvanced Diagnostics, Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K926204 | Sas One Step Pregnancy | Sa Scientific, Inc. | 1993 | — |
| +1 | K983090 | Acon Midstream Pregnancy Test | ACON Laboratories, Inc. | 1998 | — |
| +2 | K050546 | Acon +/- Midstream Pregnancy Test | ACON Laboratories, Inc. | 2005 | — |
| +2 | K042151 | Acon Spectrum HCG Midstream Pregnancy Test | ACON Laboratories, Inc. | 2004 | — |
| +2 | K032510 | Acon Quik-Check II Midstream Home Pregnancy Test | ACON Laboratories, Inc. | 2003 | — |
| +2 | K023037 | Mid Stream Pregnancy Test | Advanced Diagnostics, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983090 | Acon Midstream Pregnancy Test | 1998 | 4 |
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, K983090 (ACON Laboratories, Inc., 1998) has gone furthest, with 4 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/K926204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K926204: Sas One Step Pregnancy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926204
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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