510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K970018Substantially Equivalent

Fast Tract Transtracheal Procedure Kit

L.W. Ward and Assoc., Inc., Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970018 is the FDA 510(k) clearance record for FAST TRACT TRANSTRACHEAL PROCEDURE KIT, a class I device, cleared for L.W. Ward and Assoc., Inc. on under FDA product code LRC (Instrument, Ent Manual Surgical). FDA records list one 510(k) clearance for L.W. Ward and Assoc., Inc. As of , FDA records show no recalls naming K970018.

Clearance record

Decision date
Received
(85 days to decision)
Product code
LRC Instrument, Ent Manual Surgical
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
L.W. Ward and Assoc., Inc. 4655 Kirkwood Ct., Boulder CO
510(k) summary
Statement
Third party review
No

Clearances, product code LRC

Trailing 12 months

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

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