510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952021Substantially Equivalent

Prima Hyuperinflation System

Prima, Inc., Cleveland TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952021 is the FDA 510(k) clearance record for PRIMA HYUPERINFLATION SYSTEM, a class II device, cleared for Prima, Inc. on under FDA product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation). FDA records list 19 510(k) clearances for Prima, Inc., from to . As of , FDA records show no recalls naming K952021.

Clearance record

Decision date
Received
(24 days to decision)
Product code
BZR Mixer, Breathing Gases, Anesthesia Inhalation
Regulation
21 CFR 868.5330
Device class
Class II
Review panel
Anesthesiology
Applicant
Prima, Inc. 1300 25th St. Plz., Cleveland TN
510(k) summary
Statement
Third party review
No

Clearances, product code BZR

Trailing 12 months

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

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