Cleared Traditional

K781633 - ULTRAFILTRATION SCALE

K781633 is an FDA 510(k) clearance for ULTRAFILTRATION SCALE, manufactured by Extracorporeal Medical Specialities, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIL cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K781633 · Extracorporeal Medical Specialities, Inc. · Gastroenterology & Urology device
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Dec 1978
Decision
77d
Days
Class 2
Risk

K781633 is an FDA 510(k) clearance for the ULTRAFILTRATION SCALE. Classified as System, Dialysate Delivery, Single Pass (product code FIL), Class II - Special Controls.

Submitted by Extracorporeal Medical Specialities, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 7, 1978 after a review of 77 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

FDA 510(k) Submission Details - K781633

510(k) Number K781633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1978
Decision Date December 07, 1978
Days to Decision 77 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
54d faster than avg
Panel avg: 131d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIL Device Classification - Class 2, Special Controls

Product Code FIL System, Dialysate Delivery, Single Pass
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 - FIL System, Dialysate Delivery, Single Pass

Devices cleared under the same product code (FIL) and FDA review panel - the closest regulatory comparables to K781633.
SPS 550-IPS (INTEGRATED PATIENT STATION)
K901038 · Baxter Healthcare Corp · Apr 1990
FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM
K890329 · Fresenius USA, Inc. · May 1989
ULTRAFILTRATION MONITOR 5M9034
K771875 · Travenol Laboratories, S.A. · Nov 1977
AK-10
K771227 · Gambro, Inc. · Aug 1977
NEGATIVE PRESSURE ADAPTER 5M1350
K770137 · Travenol Laboratories, S.A. · Feb 1977