# K182927: Pulmonary Cytology Brush

- Pathway: 510(k) (Traditional)
- Applicant: Hobbs Medical, Inc.
- Decided: Feb 7, 2020 after 473 days
- Product code: BTG (Brush, Biopsy, Bronchoscope (Non-Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Jul 29, 2022 · Class II · Z-0013-2023: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-1
- Jul 29, 2022 · Class II · Z-0015-2023: Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-1

## Indications for use
The Pulmonary Cytology Brush is intended to allow brush sampling of tissue or cells from the upper or lower respiratory tract and/or to perform surveillance cultures

Source page: https://510kreport.com/device/K182927
Methodology: https://510kreport.com/methodology