510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K854029Substantially Equivalent

Respiratory Resuscitation Device

John H. Harrison, Long Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854029 is the FDA 510(k) clearance record for RESPIRATORY RESUSCITATION DEVICE, a class I device, cleared for John H. Harrison on under FDA product code CAE (Airway, Oropharyngeal, Anesthesiology). FDA records list one 510(k) clearance for John H. Harrison. As of , FDA records show no recalls naming K854029.

Clearance record

Decision date
Received
(161 days to decision)
Product code
CAE Airway, Oropharyngeal, Anesthesiology
Regulation
21 CFR 868.5110
Device class
Class I
Review panel
Anesthesiology
Applicant
John H. Harrison 4676 Long Beach Blvd. #115, Long Beach CA
Third party review
No

Clearances, product code CAE

Trailing 12 months

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

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