510(k) · Cleared
ClearedFora PNC100 Digital Pregancy Test, TD-5301 Pregancy Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taidoc Technology Corporation · LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Cleared on Oct 4, 2011 as substantially equivalent to K071930 (Blue Cross Bio-Medical Co., Ltd., 2007) after a 312-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Oct 4, 2011
- Review
- 312 days
- Class
- Class II
- Product code
- LCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071930 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK071930 One Step HCG Urine Pregnancy Test (Strip), Model B01-S, One Step HCG…Blue Cross Bio-Medical Co., Ltd. · 2007
- This deviceK103487 Fora PNC100 Digital Pregancy Test, TD-5301 Pregancy TestTaidoc Technology Corporation · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071930 | One Step HCG Urine Pregnancy Test (Strip), Model B01-S, One Step HCG Urine… | Blue Cross Bio-Medical Co., Ltd. | 2007 | — |
| 0 (this device) | K103487 | Fora PNC100 Digital Pregancy Test, TD-5301 Pregancy Test | Taidoc Technology Corporation | 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 |
|---|---|---|---|
| * | K071930 | One Step HCG Urine Pregnancy Test (Strip), Model B01-S, One Step HCG Urine Pregnancy…Summary page 1…e Pregnancy Test Common/Usual Name: Kit, Pregnancy Test, Over-the -Counter Submitter BLUE CROSS 810-MEDICAL CO., LTD. 510 (k) Number K071930 Page 2-o-3 4. Device Description The… | 2007 |
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.
- 2 other devices also cite its predicate K071930.
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?
The FORA PNC100 Digital Pregnancy Test is an in vitro diagnostic test device for the qualitative determination of human chorionic gonadotropin (hCG) in urine. It is intended for use as an aid in the early detection of pregnancy by lay users. Additional clinical examination should be performed to confirm the pregnancy. This device uses visually read lateral flow technology for the detection of hCG and provides a digitally read result. The device is…
Read the full statement (147 words)
The FORA PNC100 Digital Pregnancy Test is an in vitro diagnostic test device for the qualitative determination of human chorionic gonadotropin (hCG) in urine. It is intended for use as an aid in the early detection of pregnancy by lay users. Additional clinical examination should be performed to confirm the pregnancy.
This device uses visually read lateral flow technology for the detection of hCG and provides a digitally read result. The device is intended for home use.
The TD-5301 Pregnancy Test (Strip) is an in vitro diagnostic test device for the qualitative determination of human chorionic gonadotropin (hCG) in urine. It is intended for use as an aid in the early detection of pregnancy by lay users. Additional clinical examination should be performed to confirm the pregnancy.
This device uses visually read lateral flow technology for the detection of hCG. The device is intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103487 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103487: Fora PNC100 Digital Pregancy Test, TD-5301 Pregancy Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103487
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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