Cleared Traditional

K780682 - SINGLE PATIENT SYSTEMS

K780682 is the FDA 510(k) clearance for SINGLE PATIENT SYSTEMS by Extracorporeal Medical Specialities, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FKP) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K780682 · Extracorporeal Medical Specialities, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1978
Decision
59d
Days
Class 2
Risk

K780682 is an FDA 510(k) clearance for the SINGLE PATIENT SYSTEMS. Classified as System, Dialysate Delivery, Single Patient (product code FKP), Class II - Special Controls.

Submitted by Extracorporeal Medical Specialities, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1978 after a review of 59 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 Extracorporeal Medical Specialities, Inc. devices

Submission Details

510(k) Number K780682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1978
Decision Date June 22, 1978
Days to Decision 59 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
71d faster than avg
Panel avg: 130d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FKP System, Dialysate Delivery, Single Patient
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 - FKP System, Dialysate Delivery, Single Patient

All 25
Devices cleared under the same product code (FKP) and FDA review panel - the closest regulatory comparables to K780682.
MODELS DM-360 & DM-350-L SINGLE PATIENT
K792173 · Extracorporeal Medical Specialities, Inc. · Nov 1979
DIALYSATE DELIVERY SYSTEM
K781886 · Cordis Corp. · Jan 1979
SUITCASE KIDNEY HEMODIALYSIS SYSTEM
K781405 · Union Carbide Corp. · Dec 1978
EMODIALYSIS DEL. SYS. MODEL 7110
K771696 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1977
5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY
K761287 · Travenol Laboratories, S.A. · Jan 1977