Cleared Traditional

K820638 - PEDIATRIC SUCKER

K820638 is the FDA 510(k) clearance for PEDIATRIC SUCKER by 3M Health Care, Sarns. It is a Class 1 General & Plastic Surgery device (product code KDC) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K820638 · 3M Health Care, Sarns · General & Plastic Surgery device
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Apr 1982
Decision
32d
Days
Class 1
Risk

K820638 is an FDA 510(k) clearance for the PEDIATRIC SUCKER. Classified as Instrument, Surgical, Disposable (product code KDC), Class I - General Controls.

Submitted by 3M Health Care, Sarns (Mchenry, US). The FDA issued a Cleared decision on April 9, 1982 after a review of 32 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 3M Health Care, Sarns devices

Submission Details

510(k) Number K820638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1982
Decision Date April 09, 1982
Days to Decision 32 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
83d faster than avg
Panel avg: 115d · This submission: 32d
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 K820638.
NEGATIVE PRESSURE ARTERIAL BLOOD LINE
K830326 · Erika, Inc. · Feb 1983
KAM SUCKER
K822065 · The Anspach Effort, Inc. · Aug 1982
KOLOR KODE TM
K821166 · Devon Industries, Inc. · May 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