# K932661: Whatman Body Fluid Collection Paper:Whatman BFC180

- Pathway: 510(k) (Traditional)
- Applicant: Whatman Specialty Products, Inc.
- Decided: Apr 17, 1996 after 1,050 days
- Product code: PJC (Newborn Screening Specimen Collection Paper)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K062932: Ahlstrom Grade 226 Specimen Collection Paper (2007), 1 descendant of its own
- K121864: Perkinelmer 226 Sample Collection Devices (2013), 0 descendants of its own

## Recalls of this device
- Oct 29, 2009 · Not classified · Z-2384-2010: Neonate newborn screening card demographic and filter portion may be detached
- May 19, 2009 · Not classified · Z-1005-2010: '903' newborn Neonate screening cards have duplicate numbers assigned on cards and may result in cross-over of patient test results
- May 6, 2009 · Not classified · Z-1871-2009: The two portions of the card are coming apart prematurely.

Source page: https://510kreport.com/device/K932661
Methodology: https://510kreport.com/methodology