510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K001853Substantially Equivalent

Syringe Management System, Model Sms-1

Medtech Systems, Inc., Golden Valley MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001853 is the FDA 510(k) clearance record for SYRINGE MANAGEMENT SYSTEM, MODEL SMS-1, a class II device, cleared for Medtech Systems, Inc. on under FDA product code FMI (Needle, Hypodermic, Single Lumen). FDA records list one 510(k) clearance for Medtech Systems, Inc. As of , FDA records show no recalls naming K001853.

Clearance record

Decision date
Received
(429 days to decision)
Product code
FMI Needle, Hypodermic, Single Lumen
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Medtech Systems, Inc. 4825 Olson Memorial Hwy.,, Golden Valley MN
510(k) summary
Summary
Third party review
No

Clearances, product code FMI

Trailing 12 months
13 clearances under product code FMI in the twelve months to October 2026, March 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code FMI, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20263
April 20261
May 20260
June 20261
July 20262
August 20263
September 20261
October 20260