Cleared Traditional

K971924 - BLUNT SYRINGE CANNULA

K971924 is an FDA 510(k) clearance for BLUNT SYRINGE CANNULA, manufactured by B.Braun Medical, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 490-day FDA review.

K971924 · B.Braun Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
490d
Days
Class 2
Risk

K971924 is an FDA 510(k) clearance for the BLUNT SYRINGE CANNULA. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on September 25, 1998 after a review of 490 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all B.Braun Medical, Inc. devices

FDA 510(k) Submission Details - K971924

510(k) Number K971924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1997
Decision Date September 25, 1998
Days to Decision 490 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
361d slower than avg
Panel avg: 129d · This submission: 490d
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 455
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K971924.
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