Cleared Traditional

K811981 - ISOLATER THP

K811981 is the FDA 510(k) clearance for ISOLATER THP by Tri-Med, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOC) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K811981 · Tri-Med, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1981
Decision
22d
Days
Class 2
Risk

K811981 is an FDA 510(k) clearance for the ISOLATER THP. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Tri-Med, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 4, 1981 after a review of 22 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 Tri-Med, Inc. devices

Submission Details

510(k) Number K811981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1981
Decision Date August 04, 1981
Days to Decision 22 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
108d faster than avg
Panel avg: 130d · This submission: 22d
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 121
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K811981.
GF-180-M & GF-180-H HEMODIALYZERS
K821367 · Gambro, Inc. · May 1982
DISPOSABLE BLOOD LINE CONNECTORS
K821495 · Bentley Laboratories, Inc. · May 1982
CLIRANS TE12 HOLLOW FIBER DIALYZER
K812498 · Terumo Medical Corp. · Sep 1981
HEMASITE ACCESS MONITOR (TENT.) #RS-8200
K811977 · Renal Systems, Inc. · Jul 1981
BIONICS ARTERIAL/VENOUS FISTULA NEEDLE
K801354 · Cordis Corp. · Jul 1980
BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR
K801355 · Cordis Corp. · Jul 1980