Cleared Traditional

K010740 - FG-36UX

K010740 is the FDA 510(k) clearance for FG-36UX by Pentax Precision Instrument Corp.. It is a Class 2 Radiology device (product code ODG) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K010740 · Pentax Precision Instrument Corp. · Radiology device
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Apr 2001
Decision
35d
Days
Class 2
Risk

K010740 is an FDA 510(k) clearance for the FG-36UX, FIBER ULTRASOUND GASTROSCOPE. Classified as Endoscopic Ultrasound System, Gastroenterology-urology (product code ODG), Class II - Special Controls.

Submitted by Pentax Precision Instrument Corp. (Orangeburg, US). The FDA issued a Cleared decision on April 17, 2001 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 876.1500 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pentax Precision Instrument Corp. devices

Submission Details

510(k) Number K010740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2001
Decision Date April 17, 2001
Days to Decision 35 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 107d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODG Endoscopic Ultrasound System, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Provide Ultrasonic Visualization Of Body Cavities That Can Be Accessed By Endoscope. 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 Radiology devices follow this clearance model.

Regulatory Peers - ODG Endoscopic Ultrasound System, Gastroenterology-urology

All 36
Devices cleared under the same product code (ODG) and FDA review panel - the closest regulatory comparables to K010740.
FG-36UX FIBER ULTRASOUND GASTROSCOPE
K021276 · Pentax Precision Instrument Corp. · Sep 2002
EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
K021278 · Pentax Precision Instrument Corp. · Sep 2002
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160,
K011886 · Olympus America, Inc. · Aug 2001
OLYMPUS MH-246R BALLOON SHEATH
K961048 · Olympus America, Inc. · Sep 1996
PENTAX ULTRASOUND ENDOSCOPE MODEL FG-32UA (MODIFICATION)
K953876 · Pentax Precision Instrument Corp. · Nov 1995
ENDOSCOPIC ULTRASOUND SYSTEM TYPE 20
K926514 · Olympus Corp. · Aug 1993