Cleared Traditional

K810480 - SCANLAN SUTURE BOOTS

K810480 is the FDA 510(k) clearance for SCANLAN SUTURE BOOTS by Scanlan Intl., Inc.. It is a Class 2 Hematology device (product code KOC) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K810480 · Scanlan Intl., Inc. · Hematology device
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Mar 1981
Decision
18d
Days
Class 2
Risk

K810480 is an FDA 510(k) clearance for the SCANLAN SUTURE BOOTS. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Scanlan Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on March 13, 1981 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 876.5820 - the FDA hematology device 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 Scanlan Intl., Inc. devices

Submission Details

510(k) Number K810480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1981
Decision Date March 13, 1981
Days to Decision 18 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 113d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOC Accessories, Blood Circuit, Hemodialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 Hematology devices follow this clearance model.

Regulatory Peers - KOC Accessories, Blood Circuit, Hemodialysis

All 116
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K810480.
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BIONICS ARTERIAL/VENOUS FISTULA NEEDLE
K801354 · Cordis Corp. · Jul 1980
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K801355 · Cordis Corp. · Jul 1980
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K801356 · Cordis Corp. · Jul 1980