Cleared Traditional

WESCO BLANKET (K981093) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K981093 · Wesco, Inc. · Cardiovascular device
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Mar 2000
Decision
733d
Days
Class 2
Risk

K981093 is an FDA 510(k) clearance for the WESCO BLANKET. Classified as System, Thermal Regulating (product code DWJ), Class II - Special Controls.

Submitted by Wesco, Inc. (East Peoria, US). The FDA issued a Cleared decision on March 28, 2000 after a review of 733 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5900 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Wesco, Inc. devices

Submission Details

510(k) Number K981093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1998
Decision Date March 28, 2000
Days to Decision 733 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
608d slower than avg
Panel avg: 125d · This submission: 733d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWJ System, Thermal Regulating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5900
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - DWJ System, Thermal Regulating

All 30
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