Cleared Special

K153483 - Balloon controller PB-30

K153483 is the FDA 510(k) clearance for Balloon controller PB-30 by Fujifilm Medical Systems U.S.A, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FDF) cleared through the Special 510(k) pathway after a 12-day FDA review.

K153483 · Fujifilm Medical Systems U.S.A, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
12d
Days
Class 2
Risk

K153483 is an FDA 510(k) clearance for the Balloon controller PB-30. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Fujifilm Medical Systems U.S.A, Inc. (Wayne, US). The FDA issued a Cleared decision on December 15, 2015 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fujifilm Medical Systems U.S.A, Inc. devices

Submission Details

510(k) Number K153483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2015
Decision Date December 15, 2015
Days to Decision 12 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 130d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FDF Colonoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Colon Or Rectum For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FDF Colonoscope And Accessories, Flexible/rigid

All 67
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K153483.
Oracle EUS Balloon
K163492 · United States Endoscopy Group, Inc. · Jan 2017
Fujifilm Endoscope Models EC-600HL and EC-600LS
K162622 · Fujifilm Medical Systems U.S.A, Inc. · Oct 2016
Fujifilm Video Colonoscope Model EC-600WL V2
K160196 · Fujifilm Medical Systems U.S.A, Inc. · Feb 2016
FUJIFILM Endoscope Models EC-600HL and EC-600LS
K143732 · Fujifilm Medical Systems U.S.A, Inc. · Jul 2015
FUJIFILM 600 SERIES ENDOSCOPES
K132210 · Fujifilm Medical Systems U.S.A, Inc. · Jan 2014
EVIS EXERA III VIDEO SYSTEM
K131780 · Olympus Medical Systems Corp. · Aug 2013