510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K183516Substantially Equivalent

PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

PENTAX of America, Inc., Montvale NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183516 is the FDA 510(k) clearance record for PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U, a class II device, cleared for Pentax of America, Inc. on under FDA product code EOQ (Bronchoscope (Flexible Or Rigid)). FDA's definition for product code EOQ reads: "A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the...". FDA records list 72 510(k) clearances for Pentax of America, Inc., from to . As of , FDA records show no recalls naming K183516.

Clearance record

Decision date
Received
(262 days to decision)
Product code
EOQ Bronchoscope (Flexible Or Rigid)
Regulation
21 CFR 874.4680
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Pentax of America, Inc. 3 Paragon Dr.,, Montvale NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EOQ

Trailing 12 months
11 clearances under product code EOQ in the twelve months to October 2026, September 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EOQ, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20260
April 20262
May 20261
June 20261
July 20262
August 20260
September 20263
October 20260