Cleared Traditional

K830577 - LINEAR PUMP #4370975

K830577 is the FDA 510(k) clearance for LINEAR PUMP #4370975 by Wright Linear Pump, Inc.. It is a Class 2 Cardiovascular device (product code JOW) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K830577 · Wright Linear Pump, Inc. · Cardiovascular device
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May 1983
Decision
91d
Days
Class 2
Risk

K830577 is an FDA 510(k) clearance for the LINEAR PUMP #4370975. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Wright Linear Pump, Inc. (Walker, US). The FDA issued a Cleared decision on May 25, 1983 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - 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 Wright Linear Pump, Inc. devices

Submission Details

510(k) Number K830577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1983
Decision Date May 25, 1983
Days to Decision 91 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
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 - JOW Sleeve, Limb, Compressible

All 115
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K830577.
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KENDALL SCD THERAPEUTIC SYSTEM
K890938 · Kendall Healthcare Products Co. Div.Of Tyco Health · May 1989
MODIFIED MODEL 5320 T.E.D. COMPRESSION LIMB
K863581 · The Kendal Co. · Oct 1986
3M BRAND TOTAL LEG COMPRESSION TLC SYS.
K791894 · 3M Company · Nov 1979