510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842461Substantially Equivalent

Tongue Depressor

The Torrent Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842461 is the FDA 510(k) clearance record for TONGUE DEPRESSOR, a class I device, cleared for The Torrent Corp. on under FDA product code FMA (Depressor, Tongue, Non-Surgical). FDA records list 3 510(k) clearances for The Torrent Corp., from to . As of , FDA records show no recalls naming K842461.

Clearance record

Decision date
Received
(161 days to decision)
Product code
FMA Depressor, Tongue, Non-Surgical
Regulation
21 CFR 880.6230
Device class
Class I
Review panel
General Hospital
Applicant
The Torrent Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FMA

Trailing 12 months

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

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