Cleared Traditional

K854294 - MEDSURG SELDINGER NEEDLE

K854294 is an FDA 510(k) clearance for MEDSURG SELDINGER NEEDLE, manufactured by Medsurg Industries, Inc.. The device is a Class 2 Cardiovascular device with product code DRC cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K854294 · Medsurg Industries, Inc. · Cardiovascular device
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Jan 1986
Decision
80d
Days
Class 2
Risk

K854294 is an FDA 510(k) clearance for the MEDSURG SELDINGER NEEDLE. Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by Medsurg Industries, Inc. (Herndon, US). The FDA issued a Cleared decision on January 13, 1986 after a review of 80 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.

View all Medsurg Industries, Inc. devices

FDA 510(k) Submission Details - K854294

510(k) Number K854294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1985
Decision Date January 13, 1986
Days to Decision 80 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 125d · This submission: 80d
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 34
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K854294.
NAMIC SELDINGER INTRODUCER NEEDLE
K871378 · North American Instrument Corp. · May 1987
NAMIC ONE PART INTRODUCER NEEDLE
K871382 · North American Instrument Corp. · May 1987
MEDSURG POTT-COURNAND NEEDLE
K854293 · Medsurg Industries, Inc. · Jan 1986
EMERSON TRO/CATH TROCAR CATHETERS
K853132 · J. H. Emerson Co. · Jan 1986
VISITEC NEEDLE RANGE (CARDIOVASCULAR)
K811964 · Visitec Co. · Jul 1981
DILUTION KIT, THERMAL, COLD PAC
K781221 · Instrumentation Laboratory CO · Aug 1978