Cleared Traditional

K823092 - HEMAFLO BLOOD TUBING SETS

K823092 is an FDA 510(k) clearance for HEMAFLO BLOOD TUBING SETS, manufactured by Cobe Laboratories, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FKQ cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K823092 · Cobe Laboratories, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1982
Decision
33d
Days
Class 2
Risk

K823092 is an FDA 510(k) clearance for the HEMAFLO BLOOD TUBING SETS. Classified as System, Dialysate Delivery, Central Multiple Patient (product code FKQ), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on November 22, 1982 after a review of 33 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 Cobe Laboratories, Inc. devices

FDA 510(k) Submission Details - K823092

510(k) Number K823092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1982
Decision Date November 22, 1982
Days to Decision 33 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
97d faster than avg
Panel avg: 130d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKQ Device Classification - Class 2, Special Controls

Product Code FKQ System, Dialysate Delivery, Central Multiple 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 - FKQ System, Dialysate Delivery, Central Multiple Patient

All 34
Devices cleared under the same product code (FKQ) and FDA review panel - the closest regulatory comparables to K823092.
GAMMA STERIL. CAPILLARY FLOW DIALY-G15
K832663 · Travenol Laboratories, S.A. · Sep 1983
GAMMA STERILIZED CAPILLARY FLOW DIALYZ
K831940 · Travenol Laboratories, S.A. · Aug 1983
BICARBONATE/VARIABLE SODIUM KIT-DM-367
K830908 · Extracorporeal Medical Specialities, Inc. · Jun 1983
DISSCAP 080
K822851 · Hospal Medical Corp. · Oct 1982
CIDEX*DIALYZER DISINFECTING SOLUTION
K822535 · Surgikos, Inc. · Sep 1982
HPF 100,200,300 CAPILLARY FLOW DIALYZ
K822485 · Erika, Inc. · Aug 1982