510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K073555Substantially Equivalent

Insulin Protector

Medicool, Inc., Torrance CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K073555 is the FDA 510(k) clearance record for INSULIN PROTECTOR, a class I device, cleared for Medicool, Inc. on under FDA product code IQG (Adaptor, Holder, Syringe). FDA records list 2 510(k) clearances for Medicool, Inc., from to . As of , FDA records show no recalls naming K073555.

Clearance record

Decision date
Received
(206 days to decision)
Product code
IQG Adaptor, Holder, Syringe
Regulation
21 CFR 890.5050
Device class
Class I
Review panel
Physical Medicine
Applicant
Medicool, Inc. 20460 Gramercy Pl., Torrance CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IQG

Trailing 12 months

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

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