510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K833866Substantially Equivalent

Ace/kyle Self Tapping Cannulated Tita

Buckman Co., Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833866 is the FDA 510(k) clearance record for ACE/KYLE SELF TAPPING CANNULATED TITA, a class I device, cleared for Buckman Co., Inc. on under FDA product code JPW (Pump, Nebulizer, Electrically Powered). FDA records list 111 510(k) clearances for Buckman Co., Inc., from to . As of , FDA records show no recalls naming K833866.

Clearance record

Decision date
Received
(50 days to decision)
Product code
JPW Pump, Nebulizer, Electrically Powered
Regulation
21 CFR 874.5220
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Buckman Co., Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JPW

Trailing 12 months

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

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