Cleared Traditional

K812336 - COBE PPD 1.9

K812336 is the FDA 510(k) clearance for COBE PPD 1.9 by Cobe Laboratories, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FJG) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K812336 · Cobe Laboratories, Inc. · Gastroenterology & Urology device
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Aug 1981
Decision
13d
Days
Class 2
Risk

K812336 is an FDA 510(k) clearance for the COBE PPD 1.9. Classified as Dialyzer, Parallel Flow (product code FJG), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1981 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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

Submission Details

510(k) Number K812336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1981
Decision Date August 31, 1981
Days to Decision 13 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
117d faster than avg
Panel avg: 130d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJG Dialyzer, Parallel Flow
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - FJG Dialyzer, Parallel Flow

All 12
Devices cleared under the same product code (FJG) and FDA review panel - the closest regulatory comparables to K812336.
GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N
K862840 · Gambro, Inc. · Sep 1986
GAMBRO LUNDIA PRO 3 & 5 DIALYZER
K853406 · Gambro, Inc. · Jan 1986
COBE PPD 1.3L, #18-520-009
K820694 · Cobe Laboratories, Inc. · Mar 1982
COBE PPD .8
K810066 · Cobe Laboratories, Inc. · Jun 1981
GAMBRO LUNDIA PLATE DISP. DIALYZER
K802389 · Gambro, Inc. · Dec 1980
LUNDIA PLATE DISP.
K800424 · Gambro, Inc. · Apr 1980