510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821182Substantially Equivalent

Model ENT-4L-Flexible Nasopharyngo-

Machida America, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821182 is the FDA 510(k) clearance record for MODEL ENT-4L-FLEXIBLE NASOPHARYNGO-, a class II device, cleared for Machida America, Inc. on under FDA product code EQN (Laryngoscope, Nasopharyngoscope). FDA's definition for product code EQN reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 8 510(k) clearances for Machida America, Inc., from to . As of , FDA records show no recalls naming K821182.

Clearance record

Decision date
Received
(16 days to decision)
Product code
EQN Laryngoscope, Nasopharyngoscope
Regulation
21 CFR 874.4760
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Machida America, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EQN

Trailing 12 months
1 clearance under product code EQN in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EQN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260