Cleared Traditional

K913914 - PROGUARDII(TM) BLOOD COLLECTION DEVICE

K913914 is an FDA 510(k) clearance for PROGUARDII(TM) BLOOD COLLECTION DEVICE, manufactured by Care Medical Devices, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K913914 · Care Medical Devices, Inc. · General Hospital
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Oct 1991
Decision
35d
Days
Class 2
Risk

K913914 is an FDA 510(k) clearance for the PROGUARDII(TM) BLOOD COLLECTION DEVICE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Care Medical Devices, Inc. (Ontario, US). The FDA issued a Cleared decision on October 8, 1991 after a review of 35 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.

View all Care Medical Devices, Inc. devices

FDA 510(k) Submission Details - K913914

510(k) Number K913914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1991
Decision Date October 08, 1991
Days to Decision 35 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 129d · This submission: 35d
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 488
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K913914.
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