510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964029Unknown

Emergency Relief Kit System

Baxter Healthcare Corporation, Mcgaw Park IL / Traditional, Unknown
FDA source (opens on fda.gov)

K964029 is the FDA 510(k) clearance record for EMERGENCY RELIEF KIT SYSTEM, cleared for Baxter Healthcare Corp on under FDA product code LRR (First Aid Kit With Drug). FDA's definition for product code LRR reads: "Note: In addition to compliance with our convenience kit guidance, in regards to any drug products contained in this kit compliance with the Center for Drug Evaluation is required as well. www.fda.gov/cder/index.html - This product code...". FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K964029.

Clearance record

Decision date
Received
(161 days to decision)
Product code
LRR First Aid Kit With Drug
Device class
Not classified
Review panel
Unknown
Applicant
Baxter Healthcare Corp 1500 Waukegan Rd., Mcgaw Park IL
510(k) summary
Summary
Third party review
No

Clearances, product code LRR

Trailing 12 months

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

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