Cleared Traditional

K781795 - DIALYZER

K781795 is an FDA 510(k) clearance for DIALYZER, manufactured by Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJG cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K781795 · Medical, Inc. · Gastroenterology & Urology device
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Dec 1978
Decision
51d
Days
Class 2
Risk

K781795 is an FDA 510(k) clearance for the DIALYZER, PARALLEL FLOW DISPOSABLE. Classified as Dialyzer, Parallel Flow (product code FJG), Class II - Special Controls.

Submitted by Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 15, 1978 after a review of 51 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 Medical, Inc. devices

FDA 510(k) Submission Details - K781795

510(k) Number K781795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1978
Decision Date December 15, 1978
Days to Decision 51 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
79d faster than avg
Panel avg: 130d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJG Device Classification - Class 2, Special Controls

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 26
Devices cleared under the same product code (FJG) and FDA review panel - the closest regulatory comparables to K781795.
HD CAPILLARY FILM DIALYZER, MODEL 1001
K790533 · Travenol Laboratories, S.A. · May 1979
DIALYZER, MODEL F.M.D 150
K790001 · Hospal Medical Corp. · Mar 1979
DIALYZER, MAGNIFLO 100 PARALLEL PLATE
K781966 · Erika, Inc. · Feb 1979
LUNDIA PLATE DISPOSABLE DIALYZER
K780700 · Gambro, Inc. · Jul 1978
RP-510/RP-514 PARALLEL PLATE DIALYZERS
K780427 · Hospal Medical Corp. · May 1978
DIALYZER STANDARD, CODE 5DM1780
K772318 · Travenol Laboratories, S.A. · Jan 1978