Cleared Traditional

K831798 - DISPOSABLE SCALPELS

K831798 is the FDA 510(k) clearance for DISPOSABLE SCALPELS by I M, Inc.. It is a Class 1 General & Plastic Surgery device (product code KDC) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K831798 · I M, Inc. · General & Plastic Surgery device
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Jul 1983
Decision
46d
Days
Class 1
Risk

K831798 is an FDA 510(k) clearance for the DISPOSABLE SCALPELS. Classified as Instrument, Surgical, Disposable (product code KDC), Class I - General Controls.

Submitted by I M, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 19, 1983 after a review of 46 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 I M, Inc. devices

Submission Details

510(k) Number K831798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1983
Decision Date July 19, 1983
Days to Decision 46 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
69d faster than avg
Panel avg: 115d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 16
Devices cleared under the same product code (KDC) and FDA review panel - the closest regulatory comparables to K831798.
INSTRUMENT ORGANIZER
K914960 · O.R. Concepts, Inc. · Feb 1992
RICHARD-ALLAN VESSEL LOOPS
K900566 · Richard-Allan Medical Ind., Inc. · May 1990
C-LOOPS
K830800 · Concept, Inc. · Oct 1983
DEVO'N LOOPS
K830248 · Devon Industries, Inc. · Mar 1983
NEGATIVE PRESSURE ARTERIAL BLOOD LINE
K830326 · Erika, Inc. · Feb 1983
KAM SUCKER
K822065 · The Anspach Effort, Inc. · Aug 1982