510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921184Substantially Equivalent

Rls 9100 Rhino-Laryngeal Stroboscope

Kay Elemetrics Corp., Pine Brook NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921184 is the FDA 510(k) clearance record for RLS 9100 RHINO-LARYNGEAL STROBOSCOPE, a class I device, cleared for Kay Elemetrics Corp. on under FDA product code EQL (Laryngostroboscope). FDA records list 5 510(k) clearances for Kay Elemetrics Corp., from to . As of , FDA records show no recalls naming K921184.

Clearance record

Decision date
Received
(80 days to decision)
Product code
EQL Laryngostroboscope
Regulation
21 CFR 874.4750
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Kay Elemetrics Corp. 12 Maple Ave., Pine Brook NJ
510(k) summary
Statement
Third party review
No

Clearances, product code EQL

Trailing 12 months

FDA records hold no clearances under product code EQL in the trailing twelve months.

FDA records show no clearances under product code EQL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EQL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260