510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K840313Substantially Equivalent

Cat. 9 Anesthesiology Respiratory Dev

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

K840313 is the FDA 510(k) clearance record for CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV, a class I device, cleared for Imm Enterprises , Ltd. on under FDA product code BWB (Forceps, Tube Introduction). FDA records list 52 510(k) clearances for Imm Enterprises , Ltd., from to . As of , FDA records show no recalls naming K840313.

Clearance record

Decision date
Received
(11 days to decision)
Product code
BWB Forceps, Tube Introduction
Regulation
21 CFR 868.5780
Device class
Class I
Review panel
Anesthesiology
Applicant
Imm Enterprises , Ltd. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BWB

Trailing 12 months

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

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