Cleared Traditional

K851845 - NUMED TEMP. STYLET PACING PAROBE 1318694

K851845 is an FDA 510(k) clearance for NUMED TEMP. STYLET PACING PAROBE 1318694, manufactured by NuMED, Inc.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K851845 · NuMED, Inc. · Cardiovascular device
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Aug 1985
Decision
125d
Days
Class 2
Risk

K851845 is an FDA 510(k) clearance for the NUMED TEMP. STYLET PACING PAROBE 1318694. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on August 29, 1985 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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 NuMED, Inc. devices

FDA 510(k) Submission Details - K851845

510(k) Number K851845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1985
Decision Date August 29, 1985
Days to Decision 125 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
At panel average
Panel avg: 125d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDF Device Classification - Class 2, Special Controls

Product Code LDF Electrode, Pacemaker, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3680
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 - LDF Electrode, Pacemaker, Temporary

All 92
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K851845.
MEDTRONIC MODEL 6405
K853818 · Medtronic Vascular · Oct 1985
CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA
K851913 · Cordis Corp. · Sep 1985
115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD
K852513 · C.R. Bard, Inc. · Sep 1985
NUMED BALLOON PACING CATHETER
K851246 · NuMED, Inc. · Apr 1985
OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR
K850622 · Oscor Medical Corp. · Apr 1985
ELECATH OPEN TIP BIPOLAR PACING CATHETER
K850324 · Electro-Catheter Corp. · Mar 1985