# K012088: Nastech Mammary Aspiration Speciman Cytology Test Masct

- Pathway: 510(k) (Traditional)
- Applicant: Nastech Pharmaceutical Company, Inc.
- Decided: Dec 18, 2001 after 168 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

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

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Windy Hill Technology DucPrep™ Breast Aspirator: named in the summary without a submission number

## Most influential descendants
- K020848: NAFD 100 (2002), 0 descendants of its own

## Indications for use
The MASCT device is intended for use in the collection of mpple aspirate fluid for laboratory cytological testing.

Source page: https://510kreport.com/device/K012088
Methodology: https://510kreport.com/methodology