Cleared Traditional

K914985 - DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION

K914985 is an FDA 510(k) clearance for DISPOSABLE ANGIOGRAPHY NEEDLE, manufactured by E-Z-Em, Inc.. The device is a Class 2 Cardiovascular device with product code DRC cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K914985 · E-Z-Em, Inc. · Cardiovascular device
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Dec 1991
Decision
58d
Days
Class 2
Risk

K914985 is an FDA 510(k) clearance for the DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION. Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by E-Z-Em, Inc. (Glens Falls, US). The FDA issued a Cleared decision on December 20, 1991 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1390 - the FDA cardiovascular device oversight 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 - K914985

510(k) Number K914985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1991
Decision Date December 20, 1991
Days to Decision 58 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 125d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRC Device Classification - Class 2, Special Controls

Product Code DRC Trocar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1390
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DRC Trocar

All 50
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K914985.
ENDOSURG DISPOSABLE SECONDARY TROCAR
K940036 · Endosurg · May 1994
ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE
K924338 · Arrow Intl., Inc. · Mar 1993
R-GROUP INTL. ONE WALL PUNCTURE NEEDLE
K913267 · R-Group Intl. · Jun 1992
LAPAROSCOPIC TROCAR
K911483 · United States Endoscopy Group, Inc. · Jul 1991
SURGICAL TROCAR
K911462 · Applied Medical · Apr 1991
DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES
K900664 · Sterimed, Inc. · Jul 1990
K914985 · DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION
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