Cleared Traditional

K993125 - SAFETYTIP MULTI-SAMPLE NEEDLE, SAFETYTIP BLOOD COLLECTION SYSTEM

K993125 is an FDA 510(k) clearance for SAFETYTIP MULTI-SAMPLE NEEDLE, manufactured by Safety Medical Supply Int,., Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K993125 · Safety Medical Supply Int,., Inc. · General Hospital
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Jun 2000
Decision
274d
Days
Class 2
Risk

K993125 is an FDA 510(k) clearance for the SAFETYTIP MULTI-SAMPLE NEEDLE, SAFETYTIP BLOOD COLLECTION SYSTEM. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Safety Medical Supply Int,., Inc. (Waltham, US). The FDA issued a Cleared decision on June 20, 2000 after a review of 274 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Safety Medical Supply Int,., Inc. devices

FDA 510(k) Submission Details - K993125

510(k) Number K993125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1999
Decision Date June 20, 2000
Days to Decision 274 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 129d · This submission: 274d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 454
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K993125.
SIMPLICITY DISPOSABLE PEN NEEDLE
K002180 · Sterling Medivations, Inc. · Oct 2000
NEOLUS NEEDLE
K001572 · Terumo Europe N.V. · Aug 2000
PROTECTIV SAFETY BLOOD COLLECTION NEEDLE
K001690 · Johnson & Johnson Medical, Inc. · Jul 2000
BODYGUARD
K000441 · Vital Signs, Inc. · Apr 2000
LUER ACCESS UNIVERSAL VIAL ADAPTER
K000657 · Baxter Healthcare Corp · Mar 2000
TERUMO NEEDLE WITH LOCKING SHEATH
K000387 · Terumo Medical Corp. · Mar 2000