510(k) Report

510(k) · Cleared

Cleared

Deflectable Brush Biopsy Set

K191485510(k) TraditionalCleared Jun 26, 201922-day reviewClass II21 CFR 876.1500

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

Cook Incorporated · FDX Endoscopic Cytology Brush

Cleared on Jun 26, 2019 as substantially equivalent to K810372 (Vance Products, Inc., 1981) and 1 other predicate after a 22-day review. Its family tree reaches back 1 generation to 1977.

Decided
Jun 26, 2019
Review
22 days
Class
Class II
Product code
FDX
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K770913 (1977). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1981: 1 other ancestorReference device: K182231 · Brush Biopsy Set ; Deflectable Brush Biopsy Set · Cook Incorporated · 2019K770913 · Urological Biopsy Brush Set · Cook, Inc. · 197719801990200020102020
Other ancestors, by generation 1 generation back: 1 other ancestor K770913 · Urological Biopsy Brush Set · Cook, Inc. · 19770
  1. Root · 1 generation backK770913 Urological Biopsy Brush SetCook, Inc. · 1977
  2. This deviceK191485 Deflectable Brush Biopsy SetCook Incorporated · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K770913Urological Biopsy Brush SetCook, Inc.1977—
0 (this device)K191485Deflectable Brush Biopsy SetCook Incorporated2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
FIG. 1 — Lineage of K191485, 1977–2019Source: 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), 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 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K810372Vance Deflectable Biopsy Brush Set
Summary page 4
…ode FDX Device Class/Classification Panel: Class II, Gastroenterology/Urology Predicate Devices: • Primary predicate device: Vance Deflectable Biopsy Brush Set (K810372) • Secondary predicate device: Urological Biopsy Brush Set (K770913) Reference Devices: • Brush Biopsy Sets and Defl…
Vance Products, Inc.1981—
*K770913Urological Biopsy Brush Set
Summary page 4
…rology Predicate Devices: • Primary predicate device: Vance Deflectable Biopsy Brush Set (K810372) • Secondary predicate device: Urological Biopsy Brush Set (K770913) Reference Devices: • Brush Biopsy Sets and Deflectable Brush Biopsy Set (K182231) Device Description: The Deflectable…
Cook, Inc.1977—
†K182231Brush Biopsy Set ; Deflectable Brush Biopsy SetCook Incorporated2019—

Also cleared against K810372: 1 other device →

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?

  • None of the 2 ancestors has a recall.
  • 1 other device also cites its predicate K810372.

How does its category compare?

All FDX devices

FDX Endoscopic Cytology Brush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

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—

What is it indicated for?

The Brush Biopsy Sets are intended to obtain pathology specimens from lesions in the ureter, renal pelvis, infundibula or calyces under direct vision.

Indications for use as stated in the FDA summary.

Also cleared against K810372

1 other device cites the same predicate.

  • K182231Brush Biopsy Set ; Deflectable Brush Biopsy SetCook Incorporated · 2019

More from Cook Incorporated

181 FDA decisions under this applicant name. See the company

  • K233177Nest VT Vitrification DeviceCook Incorporated · 2024
  • K222254Gunther Tulip Vena Cava Filter Retrieval SetCook Incorporated · 2023
  • K223098Bakri Essential Postpartum BalloonCook Incorporated · 2022
  • K210734Endovascular Dilator and SetsCook Incorporated · 2021
  • K203670Extra Large Check-Flo IntroducerCook Incorporated · 2021

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
  • K182231Brush Biopsy Set ; Deflectable Brush Biopsy SetCook Incorporated · 2019
  • K181317Fusion Cytology Brush, CytoMax II Double Lumen Cytology BrushWilson-Cook Medical, Inc. · 2019

https://510kreport.com/device/K191485 · printed Nov 6, 2026

Cite this page

510(k) Report. “K191485: Deflectable Brush Biopsy Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191485

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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