Cleared Traditional

K972538 - FLOW-EZE BLUNT CANNULA (1999BC)

K972538 is the FDA 510(k) clearance for FLOW-EZE BLUNT CANNULA (1999BC) by Acacia, Inc.. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 372-day FDA review.

K972538 · Acacia, Inc. · General Hospital
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Jul 1998
Decision
372d
Days
Class 2
Risk

K972538 is an FDA 510(k) clearance for the FLOW-EZE BLUNT CANNULA (1999BC). Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Acacia, Inc. (Ojai, US). The FDA issued a Cleared decision on July 15, 1998 after a review of 372 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Acacia, Inc. devices

Submission Details

510(k) Number K972538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1997
Decision Date July 15, 1998
Days to Decision 372 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
243d slower than avg
Panel avg: 129d · This submission: 372d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 224
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K972538.
TERUMO NEEDLE WITH LOCKING SHEATH
K000387 · Terumo Medical Corp. · Mar 2000
DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER
K983750 · Deroyal Industries, Inc. · Nov 1998
BLUNT SYRINGE CANNULA
K971924 · B.Braun Medical, Inc. · Sep 1998
BECTON DICKINSON BLUNT PLASTIC CANNULA
K974363 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1998
BECTON DICKINSON TWINPAK
K974006 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1998
VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR
K963571 · Vygon Corp. · Jun 1997