Cleared Traditional

K912877 - PROFUSE INFUSION SYSTEM

K912877 is an FDA 510(k) clearance for PROFUSE INFUSION SYSTEM, manufactured by Lake Region Mfg., Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K912877 · Lake Region Mfg., Inc. · Cardiovascular device
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Sep 1991
Decision
84d
Days
Class 2
Risk

K912877 is an FDA 510(k) clearance for the PROFUSE INFUSION SYSTEM. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Lake Region Mfg., Inc. (Chaska, US). The FDA issued a Cleared decision on September 23, 1991 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Lake Region Mfg., Inc. devices

FDA 510(k) Submission Details - K912877

510(k) Number K912877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1991
Decision Date September 23, 1991
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 620
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K912877.
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K912191 · Mallinckrodt Medical · Jul 1991
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