# K013258: Inpath E2 Collector

- Pathway: 510(k) (Traditional)
- Applicant: Molecular Diagnostics
- Decided: May 31, 2002 after 242 days
- Product code: HHT (Spatula, Cervical, Cytological)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K832986 (1984). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971586: Digene Cervical Brush, Digene Corp. (1997) Summary page 1.
- K930955: Cervex-Brush, Rovers B.V. (1994) Summary page 1.

## Most influential descendants
- K072381: Softpap Cervical Cell Collector (2008), 0 descendants of its own

## Indications for use
The InPath™ e? Collector™ is intended for the collection of cervical cytology specimens for Pap test analysis. The InPath™ 2 Collector™ should not be used after the first 10 weeks of gestation in pregnant patients.

Source page: https://510kreport.com/device/K013258
Methodology: https://510kreport.com/methodology