510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K993125Substantially Equivalent

Safetytip Multi-Sample Needle, Safetytip Blood Collection System

Safety Medical Supply Int,., Inc., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993125 is the FDA 510(k) clearance record for SAFETYTIP MULTI-SAMPLE NEEDLE, SAFETYTIP BLOOD COLLECTION SYSTEM, a class II device, cleared for Safety Medical Supply Int,., Inc. on under FDA product code FMI (Needle, Hypodermic, Single Lumen). FDA records list one 510(k) clearance for Safety Medical Supply Int,., Inc. As of , FDA records show no recalls naming K993125.

Clearance record

Decision date
Received
(274 days to decision)
Product code
FMI Needle, Hypodermic, Single Lumen
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Safety Medical Supply Int,., Inc. 135 Beaver St. 4th Floor, Waltham MA
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