510(k) · Cleared
ClearedSuperdimension Triple-Needle Cytology Brush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · BTG Brush, Biopsy, Bronchoscope (Non-Rigid)
Cleared on Nov 6, 2013 as substantially equivalent to K834402 (Hobbs Medical, Inc., 1984) and 1 other predicate after a 266-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Nov 6, 2013
- Review
- 266 days
- Class
- Class II
- Product code
- BTG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K834402 (1984). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK834402 Gastrointestinal Sheath BrushHobbs Medical, Inc. · 1984 · Recalled
- This deviceK130357 Superdimension Triple-Needle Cytology BrushCovidien, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K834402 | Gastrointestinal Sheath Brush | Hobbs Medical, Inc. | 1984 | 1 |
| 0 (this device) | K130357 | Superdimension Triple-Needle Cytology Brush | Covidien, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K834402 | Gastrointestinal Sheath BrushSummary page 3…Needle Cytology Brush is substantially equivalent to the legally marketed predicate devices, Gastrointestinal Sheath Brush (KOG) by Hobbs Medical, Inc. K834402, and the Wang Bronchial Needle Brush (EOQ) by ConMed K944650. supvrDimension t Triple Needle Cytology Brush 510(k) s… | 1984 |
| * | K944650 | Wang Bronchial Needle BrushSummary page 3…lly marketed predicate devices, Gastrointestinal Sheath Brush (KOG) by Hobbs Medical, Inc. K834402, and the Wang Bronchial Needle Brush (EOQ) by ConMed K944650. supvrDimension t Triple Needle Cytology Brush 510(k) summary page 3 of 3 DEPARTME… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
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. 2013, 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?
To be utilized through a flexible endoscope or the superDimension system by
physicians who are trained in endoscopic techniques for retrieving specimens from
patients with endobronchial lesions, peripheral lung nodules, or lung masses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130357: Superdimension Triple-Needle 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/K130357
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026