510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813235Substantially Equivalent

Diss Female Air Adaptor

Timeter Instrument Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813235 is the FDA 510(k) clearance record for DISS FEMALE AIR ADAPTOR, a class II device, cleared for Timeter Instrument Corp. on under FDA product code BYK (Tent, Oxygen, Electrically Powered). FDA records list 29 510(k) clearances for Timeter Instrument Corp., from to . As of , FDA records show no recalls naming K813235.

Clearance record

Decision date
Received
(21 days to decision)
Product code
BYK Tent, Oxygen, Electrically Powered
Regulation
21 CFR 868.5710
Device class
Class II
Review panel
Anesthesiology
Applicant
Timeter Instrument Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BYK

Trailing 12 months

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

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