510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Gastrointestinal Sheath Brush

K834402510(k) TraditionalCleared Feb 4, 198452-day reviewClass II21 CFR 876.1500Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hobbs Medical, Inc. · FDX Endoscopic Cytology Brush

Cleared on Feb 4, 1984 after a 52-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
Feb 4, 1984
Review
52 days
Class
Class II
Product code
FDX
Recalls
1
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared19801990200020102020
  1. This deviceK834402 Gastrointestinal Sheath BrushHobbs Medical, Inc. · 1984
  2. Descendant · cites it directly · 0 of its ownK130357 Superdimension Triple-Needle Cytology BrushCovidien, LLC · 2013

Most influential descendants

Showing 1 of 1 · See all
  • K130357Superdimension Triple-Needle Cytology BrushCovidien, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K834402Gastrointestinal Sheath BrushHobbs Medical, Inc.1984—
+1K130357Superdimension Triple-Needle Cytology BrushCovidien, LLC2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K834402, 1984–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FDX? 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 FDX device

  1. #1 K250993 Single Use Cytology Brush V (BC-V600P-3010)score 11.7 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K130357Superdimension Triple-Needle Cytology BrushCovidien, LLC20130

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 1, 2018Class IIZ-2052-2018Labeling False and MisleadingDevice was marketed for uses outside the 510(k) clearance.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K130357 (Covidien, LLC, 2013) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FDX devices

FDX Endoscopic Cytology Brush: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FDX

1in 2025

2010: 12015: 12017: 22018: 12019: 42022: 12025: 1
2007high 4 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FDX

144in 2019

2019: 144 days median
2007high 144 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FDX

2in 2022

2021: 12022: 2
2007high 2 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FDX

11in 2025

2007: 62008: 142009: 372010: 372011: 362012: 282013: 452014: 612015: 622016: 452017: 442018: 482019: 672020: 132021: 192022: 172023: 172024: 202025: 11
2007high 67 (2019) · low 6 (2007)2025

MAUDE reports naming product code FDX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—06
20080—014
20090—037
20101—037
20110—036
20120—028
20130—045
20140—061
20151—062
20160—045
20172—044
20181—048
20194144067
20200—013
20210—119
20221—217
20230—017
20240—020
20251—011
20260—0—

More from Hobbs Medical, Inc.

21 FDA decisions under this applicant name. See the company

  • K241874Aspiration Catheter (2189)Hobbs Medical, Inc. · 2024
  • K182927Pulmonary Cytology BrushHobbs Medical, Inc. · 20202 recalls
  • K093079Touchsoft Coagulator with Banana Fitting, Model 4581 and with Universal Fitting, Model 4581-UHobbs Medical, Inc. · 2010
  • K030765Hobbs Mistifier Spray CatheterHobbs Medical, Inc. · 20032 recalls
  • K933354Hobbs Medical Cleaning BrushHobbs Medical, Inc. · 1993

Recent decisions in FDX

The FDX category page

  • K250993Single Use Cytology Brush V (BC-V600P-3010)Olympus Medical Systems Corporation · 2025
  • K220063Single Use Cytology BrushZhejiang Chuangxiang Medical Technology Co., Ltd. · 2022
  • K192908Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushesWilson-Cook Medical, Inc. · 2019
  • K191485Deflectable Brush Biopsy SetCook Incorporated · 2019
  • K182231Brush Biopsy Set ; Deflectable Brush Biopsy SetCook Incorporated · 2019

https://510kreport.com/device/K834402 · printed Nov 5, 2026

Cite this page

510(k) Report. “K834402: Gastrointestinal Sheath Brush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K834402

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026