510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972385Substantially Equivalent

Fenestrated Flexible D.i.c. Tracheostomy Tube Cuffed

Smiths Industries Medical Systems, Inc., Keene NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972385 is the FDA 510(k) clearance record for FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED, a class II device, cleared for Smiths Industries Medical Systems, Inc. on under FDA product code JOH (Tube Tracheostomy And Tube Cuff). FDA records list 22 510(k) clearances for Smiths Industries Medical Systems, Inc., from to . As of , FDA records show no recalls naming K972385.

Clearance record

Decision date
Received
(208 days to decision)
Product code
JOH Tube Tracheostomy And Tube Cuff
Regulation
21 CFR 868.5800
Device class
Class II
Review panel
Anesthesiology
Applicant
Smiths Industries Medical Systems, Inc. 15 Kit St., Keene NH
510(k) summary
Summary
Third party review
No

Clearances, product code JOH

Trailing 12 months
1 clearance under product code JOH in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JOH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260