510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813552Substantially Equivalent

Model 3000C Caloric Irrigator

Life-Tech Intl., Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813552 is the FDA 510(k) clearance record for MODEL 3000C CALORIC IRRIGATOR, a class I device, cleared for Life-Tech Intl., Inc. on under FDA product code ETP (Stimulator, Caloric-Water). FDA records list 68 510(k) clearances for Life-Tech Intl., Inc., from to . As of , FDA records show no recalls naming K813552.

Clearance record

Decision date
Received
(63 days to decision)
Product code
ETP Stimulator, Caloric-Water
Regulation
21 CFR 874.1800
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Life-Tech Intl., Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code ETP

Trailing 12 months

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

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