Cleared Traditional

K812005 - CAPILLARY PERFUSION MONITOR #LD5000

K812005 is an FDA 510(k) clearance for CAPILLARY PERFUSION MONITOR #LD5000, manufactured by Nuclear Pacific, Inc.. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K812005 · Nuclear Pacific, Inc. · Cardiovascular device
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Feb 1982
Decision
205d
Days
Class 2
Risk

K812005 is an FDA 510(k) clearance for the CAPILLARY PERFUSION MONITOR #LD5000. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Nuclear Pacific, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1982 after a review of 205 days - an extended review cycle.

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 Nuclear Pacific, Inc. devices

FDA 510(k) Submission Details - K812005

510(k) Number K812005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1981
Decision Date February 04, 1982
Days to Decision 205 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 125d · This submission: 205d
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 K812005.
PERIFLUX PF-2
K844631 · Medex, Inc. · Feb 1985
XOMED PATENCY MONITOR
K821373 · Xomed, Inc. · Jul 1982
NIHON KOHDEN BLOOD FLOWMETERS #MFV-1100
K820742 · Nihon Kohden America, Inc. · Apr 1982
EMIT TOBRAMYCIN CONTROL
K800151 · Syva Co. · Feb 1980
BLOOD FLOWMETER SYSTEM
K780302 · Medtronic Vascular · Apr 1978