510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K970811Substantially Equivalent

Disposable Cannula Tracheostomy Tube, with Inner Cannula;disposable Cannula Fenestrated Tracheostomy Tube, with Inner Cn

Pneumocare, Inc., Laguna Niguel CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970811 is the FDA 510(k) clearance record for DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN, a class II device, cleared for Pneumocare, Inc. on under FDA product code JOH (Tube Tracheostomy And Tube Cuff). FDA records list one 510(k) clearance for Pneumocare, Inc. As of , FDA records show no recalls naming K970811.

Clearance record

Decision date
Received
(618 days to decision)
Product code
JOH Tube Tracheostomy And Tube Cuff
Regulation
21 CFR 868.5800
Device class
Class II
Review panel
Anesthesiology
Applicant
Pneumocare, Inc. 23991 Ironhead Ln., Laguna Niguel CA
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