510(k) · Cleared
ClearedHome Pregnancy Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Newscen Coast Bio-Pharmaceutical Co., Ltd. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Apr 23, 2012 as substantially equivalent to K993203 (ACON Laboratories, Inc., 1999) after a 256-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Apr 23, 2012
- Review
- 256 days
- Class
- Class II
- Product code
- JHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993203 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK993203 Acon One Step Pregnancy Test Strip (Urine)ACON Laboratories, Inc. · 1999 · Recalled
- This deviceK112315 Home Pregnancy TestNewscen Coast Bio-Pharmaceutical Co., Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993203 | Acon One Step Pregnancy Test Strip (Urine) | ACON Laboratories, Inc. | 1999 | 3 |
| 0 (this device) | K112315 | Home Pregnancy Test | Newscen Coast Bio-Pharmaceutical Co., Ltd. | 2012 | — |
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 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? (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 |
|---|---|---|---|
| * | K993203 | Acon One Step Pregnancy Test Strip (Urine)Summary page 1…Name: Urine Pregnancy Test Predicate Device: ACON TM hCG One Step Pregnancy Test Strip (Urine) (K993203) Product Code: JHI 21 CFR§862.1155 / Human Chorionic Gonadlotropin Device… | 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 K993203.
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. 2012, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The y.b.t. Pregnancy Test Strip is an immunochromatographic assay for the
qualitative determination of HCG in human urine. The test is intended for use
as an aid in the early detection of pregnancy.
The y.b.t. Pregnancy Test Cassette is an immunochromatographic assay for
the qualitative determination of HOG in human urine. The test is intended for
use as an aid in the early detection of pregnancy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112315: Home 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/K112315
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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