Cleared Traditional

K820238 - COBE ACUFLEX SSN, #15-220

K820238 is an FDA 510(k) clearance for COBE ACUFLEX SSN, manufactured by Cobe Laboratories, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LFJ cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K820238 · Cobe Laboratories, Inc. · Gastroenterology & Urology device
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Mar 1982
Decision
41d
Days
Class 2
Risk

K820238 is an FDA 510(k) clearance for the COBE ACUFLEX SSN, #15-220. Classified as Catheter, Subclavian (product code LFJ), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1982 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology 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 Cobe Laboratories, Inc. devices

FDA 510(k) Submission Details - K820238

510(k) Number K820238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1982
Decision Date March 10, 1982
Days to Decision 41 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 130d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFJ Device Classification - Class 2, Special Controls

Product Code LFJ Catheter, Subclavian
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - LFJ Catheter, Subclavian

All 63
Devices cleared under the same product code (LFJ) and FDA review panel - the closest regulatory comparables to K820238.
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K810745 · Vas-Cath of Canada , Ltd. · Mar 1981
MEDCOMP SUBCLAVIAN CATHETER
K801672 · Medical Components, Inc. · Dec 1980