510(k) · Cleared
Recalled · Class II · 2022Pulmonary Cytology Brush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hobbs Medical, Inc. · BTG Brush, Biopsy, Bronchoscope (Non-Rigid)
Cleared on Feb 7, 2020 after a 473-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 2 times.
- Decided
- Feb 7, 2020
- Review
- 473 days
- Class
- Class II
- Product code
- BTG
- Recalls
- 2
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BTG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BTG device
- #1 K251279 Disposable Cytology Brush BC-202D/203D Seriesscore 9.8 · 2 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 29, 2022 | Class II | Z-0013-2023 | Process control | 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 2022-11-01 and 2025-09-01 (Devices have a… |
| Jul 29, 2022 | Class II | Z-0015-2023 | Process control | 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 2022-11-01 and 2025-09-01 (Devices have a… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All BTG devicesBTG Brush, Biopsy, Bronchoscope (Non-Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · BTG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTG
Too few BTG 510(k)s in any year since 2007 to give a median.
Recalls per year · BTG
No recall names BTG since 2007.
Adverse event reports per year · BTG
9in 2025
MAUDE reports naming product code BTG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 25 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 8 |
| 2020 | 1 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K182927 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182927: Pulmonary Cytology Brush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182927
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026