510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K052458Substantially Equivalent

Liv Medica CPR Face Mask

Liv Medica Products Pvt., Ltd., Hockessin DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K052458 is the FDA 510(k) clearance record for LIV MEDICA CPR FACE MASK, a class II device, cleared for Liv Medica Products Pvt. , Ltd. on under FDA product code CBP (Valve, Non-Rebreathing). FDA records list one 510(k) clearance for Liv Medica Products Pvt. , Ltd. As of , FDA records show no recalls naming K052458.

Clearance record

Decision date
Received
(303 days to decision)
Product code
CBP Valve, Non-Rebreathing
Regulation
21 CFR 868.5870
Device class
Class II
Review panel
Anesthesiology
Applicant
Liv Medica Products Pvt. , Ltd. 458 Briarcreek Dr., Hockessin DE
510(k) summary
Statement
Third party review
No

Clearances, product code CBP

Trailing 12 months

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

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