Cleared Traditional

K830248 - DEVO'N LOOPS

K830248 is an FDA 510(k) clearance for DEVO'N LOOPS, manufactured by Devon Industries, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KDC cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K830248 · Devon Industries, Inc. · General & Plastic Surgery device
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Mar 1983
Decision
42d
Days
Class 1
Risk

K830248 is an FDA 510(k) clearance for the DEVO'N LOOPS. Classified as Instrument, Surgical, Disposable (product code KDC), Class I - General Controls.

Submitted by Devon Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 8, 1983 after a review of 42 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 Devon Industries, Inc. devices

FDA 510(k) Submission Details - K830248

510(k) Number K830248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1983
Decision Date March 08, 1983
Days to Decision 42 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

KDC Device Classification - Class 1, General Controls

Product Code KDC Instrument, Surgical, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KDC Instrument, Surgical, Disposable

All 23
Devices cleared under the same product code (KDC) and FDA review panel - the closest regulatory comparables to K830248.
MICRO-EDGE DISPOSABLE BLADES
K832680 · Micromedics, Inc. · Oct 1983
C-LOOPS
K830800 · Concept, Inc. · Oct 1983
DISPOSABLE SCALPELS
K831798 · I M, Inc. · Jul 1983
NEGATIVE PRESSURE ARTERIAL BLOOD LINE
K830326 · Erika, Inc. · Feb 1983
KAM SUCKER
K822065 · The Anspach Effort, Inc. · Aug 1982
KOLOR KODE TM
K821166 · Devon Industries, Inc. · May 1982