Cleared Traditional

K853132 - EMERSON TRO/CATH TROCAR CATHETERS

K853132 is an FDA 510(k) clearance for EMERSON TRO/CATH TROCAR CATHETERS, manufactured by J. H. Emerson Co.. The device is a Class 2 Cardiovascular device with product code DRC cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K853132 · J. H. Emerson Co. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1986
Decision
166d
Days
Class 2
Risk

K853132 is an FDA 510(k) clearance for the EMERSON TRO/CATH TROCAR CATHETERS. Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by J. H. Emerson Co. (Cambridge, US). The FDA issued a Cleared decision on January 8, 1986 after a review of 166 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all J. H. Emerson Co. devices

FDA 510(k) Submission Details - K853132

510(k) Number K853132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1985
Decision Date January 08, 1986
Days to Decision 166 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
41d slower than avg
Panel avg: 125d · This submission: 166d
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 K853132.
NAMIC ONE PART INTRODUCER NEEDLE
K871382 · North American Instrument Corp. · May 1987
MEDSURG POTT-COURNAND NEEDLE
K854293 · Medsurg Industries, Inc. · Jan 1986
MEDSURG SELDINGER NEEDLE
K854294 · Medsurg Industries, Inc. · Jan 1986
VISITEC NEEDLE RANGE (CARDIOVASCULAR)
K811964 · Visitec Co. · Jul 1981
DILUTION KIT, THERMAL, COLD PAC
K781221 · Instrumentation Laboratory CO · Aug 1978
NEEDLES USED IN ANGIOGRAPHIC PROCED.
K772369 · Argon Medical Corp. · Jan 1978