Cleared Traditional

K811280 - FLEX-TEMPLATE

K811280 is the FDA 510(k) clearance for FLEX-TEMPLATE by Mick Radio-Nuclear Instruments, Inc.. It is a Class 1 General & Plastic Surgery device (product code KDC) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K811280 · Mick Radio-Nuclear Instruments, Inc. · General & Plastic Surgery device
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Jun 1981
Decision
25d
Days
Class 1
Risk

K811280 is an FDA 510(k) clearance for the FLEX-TEMPLATE. Classified as Instrument, Surgical, Disposable (product code KDC), Class I - General Controls.

Submitted by Mick Radio-Nuclear Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1981 after a review of 25 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 Mick Radio-Nuclear Instruments, Inc. devices

Submission Details

510(k) Number K811280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1981
Decision Date June 02, 1981
Days to Decision 25 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
90d faster than avg
Panel avg: 115d · This submission: 25d
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 15
Devices cleared under the same product code (KDC) and FDA review panel - the closest regulatory comparables to K811280.
KOLOR KODE TM
K821166 · Devon Industries, Inc. · May 1982
PEDIATRIC SUCKER
K820638 · 3M Health Care, Sarns · Apr 1982
TIP WIPE
K811712 · Devon Industries, Inc. · Jul 1981
DAVIS & GECK NEEDLE/SHARPS COUNTER
K811191 · Davis & Geck, Inc. · May 1981
SEARLE VASCULAR LOOPS
K802485 · G.D. Searle and Co. · Feb 1981
SWR DISPOSABLE PREP RAZOR
K810112 · G.D. Searle and Co. · Feb 1981