510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853971Substantially Equivalent

Regulator-Inhalator System

Stephenson Industries, Inc., Farmingdale NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853971 is the FDA 510(k) clearance record for REGULATOR-INHALATOR SYSTEM, a class II device, cleared for Stephenson Industries, Inc. on under FDA product code BTL (Ventilator, Emergency, Powered (Resuscitator)). FDA records list 4 510(k) clearances for Stephenson Industries, Inc., from to . As of , FDA records show no recalls naming K853971.

Clearance record

Decision date
Received
(74 days to decision)
Product code
BTL Ventilator, Emergency, Powered (Resuscitator)
Regulation
21 CFR 868.5925
Device class
Class II
Review panel
Anesthesiology
Applicant
Stephenson Industries, Inc. P. O. Box 1000, Farmingdale NJ
Third party review
No

Clearances, product code BTL

Trailing 12 months

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

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