Cleared Traditional

K000369 - VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5

Also marketed or referenced as:
VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDER

K000369 is an FDA 510(k) clearance for VACUFLOW+ BLOOD COLLECTION SET, manufactured by Medpro Technologies, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K000369 · Medpro Technologies, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
55d
Days
Class 2
Risk

K000369 is an FDA 510(k) clearance for the VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Medpro Technologies, Inc. (Appollo Beach, US). The FDA issued a Cleared decision on March 30, 2000 after a review of 55 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K000369

510(k) Number K000369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2000
Decision Date March 30, 2000
Days to Decision 55 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
74d faster than avg
Panel avg: 129d · This submission: 55d
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 695
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K000369.
PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01
K001098 · Pro. Duct Health, Inc. · May 2000
GETTIG GUARD
K000455 · Gettig Pharmaceutical Instrument Co. · Apr 2000
BODYGUARD
K000441 · Vital Signs, Inc. · Apr 2000
PORTSETT
K000085 · Portsett, Inc. · Mar 2000
LUER ACCESS UNIVERSAL VIAL ADAPTER
K000657 · Baxter Healthcare Corp · Mar 2000
TERUMO NEEDLE WITH LOCKING SHEATH
K000387 · Terumo Medical Corp. · Mar 2000
K000369 · VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5
Download PDF FDA Summary Medpro Technologies, …