510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063268Substantially Equivalent

Cpap/vpap Masks, Models 1225, 1205 and 1235

Hsiner Co., Ltd., Temecula CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063268 is the FDA 510(k) clearance record for CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235, a class II device, cleared for Hsiner Co., Ltd. on under FDA product code BZD (Ventilator, Non-Continuous (Respirator)). FDA records list 9 510(k) clearances for Hsiner Co., Ltd., from to . As of , FDA records show one recall naming K063268.

Clearance record

Decision date
Received
(116 days to decision)
Product code
BZD Ventilator, Non-Continuous (Respirator)
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
Hsiner Co., Ltd. 29201 Via Norte, Temecula CA
510(k) summary
Summary PDF
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