510(k) · Cleared
ClearedSurearly Pregnancy Test Strip, Surearly Digital Pregnancy Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sugentech, Inc. · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Apr 7, 2016 as substantially equivalent to K060128 (Unipath, Ltd., 2006) after a 560-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Apr 7, 2016
- Review
- 560 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060128 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK060128 Clearblue Easy Digital Pregnancy TestUnipath, Ltd. · 2006
- This deviceK142754 Surearly Pregnancy Test Strip, Surearly Digital Pregnancy TestSugentech, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060128 | Clearblue Easy Digital Pregnancy Test | Unipath, Ltd. | 2006 | — |
| 0 (this device) | K142754 | Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test | Sugentech, Inc. | 2016 | — |
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 |
|---|---|---|---|
| * | K060128 | Clearblue Easy Digital Pregnancy TestSummary page 5…5-2 (of 6) 3. Predicate Device Trade Name Clearblue Easy Digital Pregnancy Test 510(k) Number K060128 Submitter Unipath Ltd. 4. Device Description Both Surearly™ Pregnancy Test Strip and Surearly… | 2006 |
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 no recall.
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. 2016, 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?
Surearly™ Pregnancy Test Strip is an in vitro diagnostic medical device for the rapid detection of human chorionic gonadotropin (hCG) in urine. The test is for the qualitative detection of hCG to aid in the early determination of pregnancy. It is intended for over-the-counter (OTC) use only.
Surearly™ Digital Pregnancy Test is an in vitro diagnostic medical device for the rapid detection of human chorionic gonadotropin (hCG) in urine. The test is for the qualitative detection of hCG to aid in the early determination of pregnancy. It is intended for over-the-counter (OTC) use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142754: Surearly Pregnancy Test Strip, Surearly Digital 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/K142754
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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