510(k) · Cleared
ClearedAcon Midstream Pregnancy Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Nov 18, 1998 as substantially equivalent to K926204 (Sa Scientific, Inc., 1993) after a 76-day review. Its family tree reaches back 1 generation to 1993. 4 later devices descend from it.
- Decided
- Nov 18, 1998
- Review
- 76 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926204 (1993). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK926204 Sas One Step PregnancySa Scientific, Inc. · 1993
- This deviceK983090 Acon Midstream Pregnancy TestACON Laboratories, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK050546 Acon +/- Midstream Pregnancy TestACON Laboratories, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK042151 Acon Spectrum HCG Midstream Pregnancy TestACON Laboratories, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK032510 Acon Quik-Check II Midstream Home Pregnancy TestACON Laboratories, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK023037 Mid Stream Pregnancy TestAdvanced Diagnostics, Inc. · 2003
Most influential descendants
Showing 4 of 4 · See all- K050546Acon +/- Midstream Pregnancy TestACON Laboratories, Inc. · 2005 · cites it directly0descendants
- K042151Acon Spectrum HCG Midstream Pregnancy TestACON Laboratories, Inc. · 2004 · cites it directly0descendants
- K032510Acon Quik-Check II Midstream Home Pregnancy TestACON Laboratories, Inc. · 2003 · cites it directly0descendants
- K023037Mid Stream Pregnancy TestAdvanced Diagnostics, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926204 | Sas One Step Pregnancy | Sa Scientific, Inc. | 1993 | — |
| 0 (this device) | K983090 | Acon Midstream Pregnancy Test | ACON Laboratories, Inc. | 1998 | — |
| +1 | K050546 | Acon +/- Midstream Pregnancy Test | ACON Laboratories, Inc. | 2005 | — |
| +1 | K042151 | Acon Spectrum HCG Midstream Pregnancy Test | ACON Laboratories, Inc. | 2004 | — |
| +1 | K032510 | Acon Quik-Check II Midstream Home Pregnancy Test | ACON Laboratories, Inc. | 2003 | — |
| +1 | K023037 | Mid Stream Pregnancy Test | Advanced Diagnostics, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LCX? 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 LCX device
- #1 K251040 MissLan® Early Detection Digital Pregnancy…score 11.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K926204 | Sas One Step PregnancySummary page 1…nadotropin (hCG) Test System C. Legally Marketed Device The ACON™ Midstream Pregnancy Test has been determined to be substantially equivalent to the SAS Pregnancy Test (K926204) currently in commercial distribution by SA Scientific, San Antonio, TX. D. Device Description The ACON Midstream Pregnancy Tes… | 1993 |
What descends from it? (4)
4 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?
- Its one ancestor has no recall.
- Of its descendants, K050546 (ACON Laboratories, Inc., 2005) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LCX devicesLCX Kit, Test, Pregnancy, Hcg, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LCX
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LCX
102in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LCX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCX
6in 2025
MAUDE reports naming product code LCX, 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 | 223 | 0 | 26 |
| 2008 | 0 | — | 0 | 45 |
| 2009 | 2 | — | 1 | 8 |
| 2010 | 0 | — | 2 | 21 |
| 2011 | 5 | 234 | 0 | 19 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 8 | 152 | 0 | 3 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 4 | 162 | 0 | 2 |
| 2019 | 7 | 50 | 0 | 3 |
| 2020 | 2 | — | 0 | 3 |
| 2021 | 2 | — | 0 | 4 |
| 2022 | 6 | 264 | 0 | 12 |
| 2023 | 2 | — | 8 | 6 |
| 2024 | 10 | 132 | 0 | 3 |
| 2025 | 5 | 102 | 1 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ACON™ Midstream Pregnancy Test is intended for home use (over-the-counter) for the qualitative detection of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983090 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983090: Acon Midstream Pregnancy Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983090
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026