Cleared Traditional

K831915 - SAFETY PINS & RUBBER BANDS

K831915 is the FDA 510(k) clearance for SAFETY PINS & RUBBER BANDS by Ormed Mfg., Inc.. It is a Class 1 General & Plastic Surgery device (product code KDC) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K831915 · Ormed Mfg., Inc. · General & Plastic Surgery device
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Sep 1983
Decision
90d
Days
Class 1
Risk

K831915 is an FDA 510(k) clearance for the SAFETY PINS & RUBBER BANDS. Classified as Instrument, Surgical, Disposable (product code KDC), Class I - General Controls.

Submitted by Ormed Mfg., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Ormed Mfg., Inc. devices

Submission Details

510(k) Number K831915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1983
Decision Date September 12, 1983
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
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 17
Devices cleared under the same product code (KDC) and FDA review panel - the closest regulatory comparables to K831915.
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
DISPOSABLE SCALPELS
K831798 · I M, Inc. · Jul 1983
DEVO'N LOOPS
K830248 · Devon Industries, Inc. · Mar 1983
NEGATIVE PRESSURE ARTERIAL BLOOD LINE
K830326 · Erika, Inc. · Feb 1983