# K020848: NAFD 100

- Pathway: 510(k) (Traditional)
- Applicant: Neomatrix, LLC
- Decided: Sep 23, 2002 after 192 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
Longest line of descent: 1 generation back to K950750 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000135: Pro.Duct Catheter, Model CTH03, Pro. Duct Health, Inc. (2000)
- K012088: Nastech Mammary Aspiration Speciman Cytology Test Masct, Nastech Pharmaceutical Company, Inc. (2001)
- K950750: Medelas Breast Pump, Medela, Inc. (1995) Summary page 1.

## Indications for use
The NAFD 100 (and its components) is indicated for the collection of nipple aspirate fluid for cytological evaluation. The collected fluid can be used in the determination and/or differentiation of normal versus pre-malignant versus malignant cells.

Source page: https://510kreport.com/device/K020848
Methodology: https://510kreport.com/methodology