510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K981266Substantially Equivalent

Auto-Injector, Sure-Inject 2000

Mighty Mo, Corp., St. Petersburg FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981266 is the FDA 510(k) clearance record for AUTO-INJECTOR, SURE-INJECT 2000, a class II device, cleared for Mighty Mo, Corp. on under FDA product code KZH (Introducer, Syringe Needle). FDA records list one 510(k) clearance for Mighty Mo, Corp. As of , FDA records show no recalls naming K981266.

Clearance record

Decision date
Received
(98 days to decision)
Product code
KZH Introducer, Syringe Needle
Regulation
21 CFR 880.6920
Device class
Class II
Review panel
General Hospital
Applicant
Mighty Mo, Corp. 150 2nd Ave. Norh, St. Petersburg FL
510(k) summary
Statement
Third party review
No

Clearances, product code KZH

Trailing 12 months

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

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