510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010526Substantially Equivalent

Modification to the Grip

Elcare Innovations, Inc., Burleson TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010526 is the FDA 510(k) clearance record for MODIFICATION TO THE GRIP, a class II device, cleared for Elcare Innovations, Inc. 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 Elcare Innovations, Inc. As of , FDA records show no recalls naming K010526.

Clearance record

Decision date
Received
(294 days to decision)
Product code
LIX Aid, Cardiopulmonary Resuscitation
Regulation
21 CFR 870.5210
Device class
Class II
Review panel
Cardiovascular
Applicant
Elcare Innovations, Inc. 7101 Stephenson-Levey Rd., Burleson TX
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