# K941090: Unistep HCG Pregnancy Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: Biotech Atlantic, Inc.
- Decided: Jun 2, 1994 after 86 days
- Product code: DHA (System, Test, Human Chorionic Gonadotropin)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K960174: Unimark Midstream Pregnancy Test Stick (1996), 16 descendants of its own
- K032992: Unimark Home Pregnancy Test Device (2003), 15 descendants of its own
- K043443: One Step HCG Urine Pregnancy Test (2005), 14 descendants of its own
- K173229: Preview Digital Pregnancy Test (2018), 2 descendants of its own
- K222305: MissLan™ Digital Pregnancy Rapid Test (2022), 1 descendant of its own

Source page: https://510kreport.com/device/K941090
Methodology: https://510kreport.com/methodology