510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823517Substantially Equivalent

The Kline Applicator

Kline Technologies, Ltd., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823517 is the FDA 510(k) clearance record for THE KLINE APPLICATOR, a class I device, cleared for Kline Technologies, Ltd. on under FDA product code HGD (Applicator, Vaginal). FDA records list one 510(k) clearance for Kline Technologies, Ltd. As of , FDA records show no recalls naming K823517.

Clearance record

Decision date
Received
(50 days to decision)
Product code
HGD Applicator, Vaginal
Regulation
21 CFR 884.4520
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Kline Technologies, Ltd. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HGD

Trailing 12 months

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

FDA records show no clearances under product code HGD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HGD, 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