# K942435: Saliva Sampler

- Pathway: 510(k) (Traditional)
- Applicant: Saliva Diagnostic Systems, Inc.
- Decided: Aug 21, 1995 after 458 days
- Product code: PJD (Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 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
- K183048: Quantisal II Oral Fluid Collection Device (2019), 3 descendants of its own
- K200801: Quantisal Oral Fluid Collection Device (2020), 1 descendant of its own
- K984361: Oral-Eze Oral Fluid Collection System (1999), 1 descendant of its own
- K232898: Quantisal™ Oral Fluid Collection Device (2023), 0 descendants of its own
- K223781: Quantisal™ II Oral Fluid Collection Device (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K942435
Methodology: https://510kreport.com/methodology