Class Class II
Green Card Bowie-Dick Test (BD115) (K250172)
Description
Green Card Bowie-Dick Test (BD115) by Steritec Products, Inc. (A Getinge Company), an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250172
Clearance Date2025-02-20
Clearance TypeSpecial
Product CodeJOJ
Regulation Number880.2800
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250172
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Green Card Bowie-Dick Test (BD115) (K250172) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K024293 | BOWIE-DICK MINI PAK, MODEL BD 115 | Steritec Products, Inc. | 2003 |
Trace the full predicate network for K250172
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.