Cleared Traditional

K802485 - SEARLE VASCULAR LOOPS

K802485 is an FDA 510(k) clearance for SEARLE VASCULAR LOOPS, manufactured by G.D. Searle and Co.. The device is a Class 1 General & Plastic Surgery device with product code KDC cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K802485 · G.D. Searle and Co. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Feb 1981
Decision
125d
Days
Class 1
Risk

K802485 is an FDA 510(k) clearance for the SEARLE VASCULAR LOOPS. Classified as Instrument, Surgical, Disposable (product code KDC), Class I - General Controls.

Submitted by G.D. Searle and Co. (Mchenry, US). The FDA issued a Cleared decision on February 12, 1981 after a review of 125 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 G.D. Searle and Co. devices

FDA 510(k) Submission Details - K802485

510(k) Number K802485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1980
Decision Date February 12, 1981
Days to Decision 125 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
10d slower than avg
Panel avg: 115d · This submission: 125d
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 24
Devices cleared under the same product code (KDC) and FDA review panel - the closest regulatory comparables to K802485.
DAVIS & GECK NEEDLE/SHARPS COUNTER
K811191 · Davis & Geck, Inc. · May 1981
SURGICAL STAPLE REMOVER
K811120 · Acme United Corp. · May 1981
VASCULAR TIE (VAS-TIE)
K810080 · Sil-Med Corp. · Apr 1981
SWR DISPOSABLE PREP RAZOR
K810112 · G.D. Searle and Co. · Feb 1981
SURGITEK MEDI-LOOPS
K803156 · Medical Engineering Corp. · Jan 1981
COBE CENTRY 2 VARIABLE CONCENTRATE-18-
K802895 · Cobe Laboratories, Inc. · Dec 1980