510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082138Substantially Equivalent

Airgent, Model Ag7000010

Perfaction, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082138 is the FDA 510(k) clearance record for AIRGENT, MODEL AG7000010, a class II device, cleared for Perfaction, Inc. on under FDA product code KZE (Injector, Fluid, Non-Electrically Powered). FDA records list one 510(k) clearance for Perfaction, Inc. As of , FDA records show no recalls naming K082138.

Clearance record

Decision date
Received
(178 days to decision)
Product code
KZE Injector, Fluid, Non-Electrically Powered
Regulation
21 CFR 880.5430
Device class
Class II
Review panel
General Hospital
Applicant
Perfaction, Inc. 555 Thirteenth St. NW, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KZE

Trailing 12 months

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

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