510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971067Substantially Equivalent

Digi-Injector

Medical Instrument Development Laboratories, Inc., San Leandro CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971067 is the FDA 510(k) clearance record for DIGI-INJECTOR, a class II device, cleared for Medical Instrument Development Laboratories, Inc. on under FDA product code MRH (Pump, Infusion, Ophthalmic). FDA records list 23 510(k) clearances for Medical Instrument Development Laboratories, Inc., from to . As of , FDA records show no recalls naming K971067.

Clearance record

Decision date
Received
(179 days to decision)
Product code
MRH Pump, Infusion, Ophthalmic
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Medical Instrument Development Laboratories, Inc. 14477 Catalina St., San Leandro CA
510(k) summary
Statement
Third party review
No

Clearances, product code MRH

Trailing 12 months
1 clearance under product code MRH in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MRH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260