Cleared Traditional

K880778 - MEDSURG ACUTE DIALYSIS TRAY

K880778 is an FDA 510(k) clearance for MEDSURG ACUTE DIALYSIS TRAY, manufactured by Medsurg Industries, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LFJ cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K880778 · Medsurg Industries, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1988
Decision
140d
Days
Class 2
Risk

K880778 is an FDA 510(k) clearance for the MEDSURG ACUTE DIALYSIS TRAY. Classified as Catheter, Subclavian (product code LFJ), Class II - Special Controls.

Submitted by Medsurg Industries, Inc. (Herndon, US). The FDA issued a Cleared decision on July 15, 1988 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medsurg Industries, Inc. devices

FDA 510(k) Submission Details - K880778

510(k) Number K880778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1988
Decision Date July 15, 1988
Days to Decision 140 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
9d slower than avg
Panel avg: 131d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFJ Device Classification - Class 2, Special Controls

Product Code LFJ Catheter, Subclavian
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 - LFJ Catheter, Subclavian

All 63
Devices cleared under the same product code (LFJ) and FDA review panel - the closest regulatory comparables to K880778.
MODIFIED VAS-CATH CATHETER REPAIR KIT
K890099 · Vas-Cath, Inc. · Apr 1989
IMPRA DUAL LUMEN SUBCLAVIAN - FEMORAL CATHETER
K883592 · Impra, Inc. · Dec 1988
VAS-CATH CATHETER REPAIR KIT
K883768 · Vas-Cath, Inc. · Nov 1988
DESERET SUBCLAVIAN HEMODIALYSIS CATHETER
K881695 · Deseret Medical, Inc. · Jun 1988
VAS-CATH FLEXXICON DUAL LUMEN DIALYSIS CATHETER
K881743 · Vas-Cath, Inc. · Jun 1988
MODIFIED SHILEY DUAL LUMEN SUBCLAVIAN CANNULA
K881290 · Shiley, Inc. · Apr 1988