510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K992384Substantially Equivalent

Cpap/pro CPAP Interface

Stevenson Industries, Inc., Pleasant Hill CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992384 is the FDA 510(k) clearance record for CPAP/PRO CPAP INTERFACE, a class II device, cleared for Stevenson Industries, Inc. on under FDA product code BZD (Ventilator, Non-Continuous (Respirator)). FDA records list 2 510(k) clearances for Stevenson Industries, Inc., from to . As of , FDA records show no recalls naming K992384.

Clearance record

Decision date
Received
(138 days to decision)
Product code
BZD Ventilator, Non-Continuous (Respirator)
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
Stevenson Industries, Inc. 200 Gregory Ln. Suite C-100, Pleasant Hill CA
510(k) summary
Summary
Third party review
No

Clearances, product code BZD

Trailing 12 months
11 clearances under product code BZD in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BZD, trailing twelve months
MonthClearances
November 20250
December 20252
January 20262
February 20260
March 20260
April 20262
May 20262
June 20261
July 20261
August 20260
September 20261
October 20260