Cleared Traditional

K821138 - TS-180 SERIES TUBING SET

K821138 is the FDA 510(k) clearance for TS-180 SERIES TUBING SET by Extracorporeal Medical Specialities, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FJK) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K821138 · Extracorporeal Medical Specialities, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1982
Decision
19d
Days
Class 2
Risk

K821138 is an FDA 510(k) clearance for the TS-180 SERIES TUBING SET. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Extracorporeal Medical Specialities, Inc. (King Of Prussia, US). The FDA issued a Cleared decision on May 10, 1982 after a review of 19 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 K821138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1982
Decision Date May 10, 1982
Days to Decision 19 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
111d faster than avg
Panel avg: 130d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve
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 - FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve

All 21
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K821138.
ASA BLOOD TUBING LINES
K854271 · Organon Teknika Corp. · Nov 1985
THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101
K831424 · Extracorporeal Medical Specialities, Inc. · Oct 1983
BLOOD LINE SETS FOR HEMOFILTRATION
K830677 · Gambro, Inc. · Apr 1983
MALE LUER CONNECTOR & HINGED CAP
K820169 · Extracorporeal Medical Specialities, Inc. · Feb 1982
ARTERIOVENOUS BLOOD TUBING SETS
K802874 · Extracorporeal Medical Specialities, Inc. · Nov 1980
COBE HEMOFLO BLOOD TUBING SETS
K801211 · Cobe Laboratories, Inc. · Jul 1980