510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K003937Substantially Equivalent

CPR Ezy Mask and Pad

Medteq Innovations Pty, Ltd., Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003937 is the FDA 510(k) clearance record for CPR EZY MASK AND PAD, a class II device, cleared for Medteq Innovations Pty, Ltd. on under FDA product code LIX (Aid, Cardiopulmonary Resuscitation). FDA's definition for product code LIX reads: "CPR Aid device WITH feedback (visual, audio or both) on one or more CPR parameters (e.g., rate, depth, ventilation ratio, etc.), and contains software. Provides real-time feedback on CPR performance. Feedback can be audio, visual or both...". FDA records list one 510(k) clearance for Medteq Innovations Pty, Ltd. As of , FDA records show no recalls naming K003937.

Clearance record

Decision date
Received
(168 days to decision)
Product code
LIX Aid, Cardiopulmonary Resuscitation
Regulation
21 CFR 870.5210
Device class
Class II
Review panel
Cardiovascular
Applicant
Medteq Innovations Pty, Ltd. 7361 Calhoun Pl., Suite 500, Rockville MD
510(k) summary
Summary
Third party review
No

Clearances, product code LIX

Trailing 12 months

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

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