Cleared Traditional

K831433 - EXTRASENSR ULTRAFILTRATION MONITOR

K831433 is the FDA 510(k) clearance for EXTRASENSR ULTRAFILTRATION MONITOR by Extracorporeal Medical Specialities, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOC) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K831433 · Extracorporeal Medical Specialities, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1983
Decision
29d
Days
Class 2
Risk

K831433 is an FDA 510(k) clearance for the EXTRASENSR ULTRAFILTRATION MONITOR. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Extracorporeal Medical Specialities, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1983 after a review of 29 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 K831433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1983
Decision Date June 02, 1983
Days to Decision 29 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
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOC Accessories, Blood Circuit, Hemodialysis
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 80
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K831433.
CLIRANS TAF06 HOLLOW FIBER DIALYZER
K832252 · Terumo Medical Corp. · Aug 1983
GF-180-L HOLLOW FIBER HEMODIALYSIS
K831606 · Gambro, Inc. · Jun 1983
CLIRANS TAF 120 HOLLOW FIBER DIALYZ. &
K831482 · Terumo Medical Corp. · Jun 1983
LUNDIA 10-3-L PARALLEL FLOW DIALYZER
K831338 · Gambro, Inc. · May 1983
LUNDIA 10-2-N PARALLEL FLOW DIALYZER
K830905 · Gambro, Inc. · Apr 1983
C-DAK ARTIFICIAL KIDNEY
K830729 · Cordis Corp. · Mar 1983