510(k) · Cleared
ClearedAtlas Home Pregnancy Test (Midstream Format) Model 70172001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atlas Medical · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Aug 3, 2011 as substantially equivalent to K993317 (ACON Laboratories, Inc., 1999) after a 314-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Aug 3, 2011
- Review
- 314 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993317 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK993317 Acon HCG One Step Pregnancy Test Device (Urine)ACON Laboratories, Inc. · 1999 · Recalled
- This deviceK102760 Atlas Home Pregnancy Test (Midstream Format) Model 70172001Atlas Medical · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993317 | Acon HCG One Step Pregnancy Test Device (Urine) | ACON Laboratories, Inc. | 1999 | 2 |
| 0 (this device) | K102760 | Atlas Home Pregnancy Test (Midstream Format) Model 70172001 | Atlas Medical | 2011 | — |
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 |
|---|---|---|---|
| * | K993317 | Acon HCG One Step Pregnancy Test Device (Urine)Summary page 1…quivalence legally marketed device: Atlas Home Pregnancy Test (Midstream Format) has been determined to be substantially equivalent to ACON TMOne Step Test Device (K9933 17) currently in commercial distribution by Acon Laboratories, Inc. 4- Device description: Atlas Home Pregnancy Test (Midstre… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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 a recall.
- 1 other device also cites its predicate K993317.
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. 2011, this device’s year, is highlighted.
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?
Atlas Home Pregnancy Test (Midstream Format) is a home use (OTC) rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in the urine to aid in the early detection of pregnancy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102760 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102760: Atlas Home Pregnancy Test (Midstream Format) Model 70172001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102760
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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