Cleared Traditional

K820161 - AXIOM LIG-A-BOOTS

K820161 is an FDA 510(k) clearance for AXIOM LIG-A-BOOTS, manufactured by Axiom Medical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KDC cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K820161 · Axiom Medical, Inc. · General & Plastic Surgery device
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Mar 1982
Decision
54d
Days
Class 1
Risk

K820161 is an FDA 510(k) clearance for the AXIOM LIG-A-BOOTS. Classified as Instrument, Surgical, Disposable (product code KDC), Class I - General Controls.

Submitted by Axiom Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 15, 1982 after a review of 54 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 Axiom Medical, Inc. devices

FDA 510(k) Submission Details - K820161

510(k) Number K820161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1982
Decision Date March 15, 1982
Days to Decision 54 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
61d faster than avg
Panel avg: 115d · This submission: 54d
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 K820161.
KAM SUCKER
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KOLOR KODE TM
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PEDIATRIC SUCKER
K820638 · 3M Health Care, Sarns · Apr 1982
TIP WIPE
K811712 · Devon Industries, Inc. · Jul 1981
FLEX-TEMPLATE
K811280 · Mick Radio-Nuclear Instruments, Inc. · Jun 1981
DAVIS & GECK NEEDLE/SHARPS COUNTER
K811191 · Davis & Geck, Inc. · May 1981