Cleared Traditional

K854500 - HEATER PROBE-ACCESS FOR MEDPACIFIC LD5000 LASER -

K854500 is an FDA 510(k) clearance for HEATER PROBE-ACCESS FOR MEDPACIFIC LD50..., manufactured by Medpacific Corp.. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K854500 · Medpacific Corp. · Cardiovascular device
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Feb 1986
Decision
106d
Days
Class 2
Risk

K854500 is an FDA 510(k) clearance for the HEATER PROBE-ACCESS FOR MEDPACIFIC LD5000 LASER -. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Medpacific Corp. (Seattle, US). The FDA issued a Cleared decision on February 26, 1986 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2100 - 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 Medpacific Corp. devices

FDA 510(k) Submission Details - K854500

510(k) Number K854500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1985
Decision Date February 26, 1986
Days to Decision 106 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 125d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPW Device Classification - Class 2, Special Controls

Product Code DPW Flowmeter, Blood, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2100
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 - DPW Flowmeter, Blood, Cardiovascular

All 81
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K854500.
VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES
K862720 · Sonicaid, Inc. · Nov 1986
HIGH VELOCITY CW DOPPLER SYSTEM
K862841 · Biosound, Inc. · Nov 1986
MILLAR PULSED DOPPLER VELOCIMETER
K860766 · Millar Instruments, Inc. · Jul 1986
TECA TC2-64 TRANSCRANIAL DOPPLER
K850137 · Teca, Inc. · Aug 1985
RECOMED BLOOD-FLOW METER H236-052-02
K840522 · Litton Medical Electronics · May 1985
PERIFLUX PF-2
K844631 · Medex, Inc. · Feb 1985