Cleared Traditional

CATHETER INSERTION TRAY (K962849) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K962849 · Medcare Medical Group, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 1996
Decision
77d
Days
Class 2
Risk

K962849 is an FDA 510(k) clearance for the CATHETER INSERTION TRAY. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Medcare Medical Group, Inc. (East Swanzey, US). The FDA issued a Cleared decision on October 7, 1996 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital 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 Medcare Medical Group, Inc. devices

Submission Details

510(k) Number K962849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1996
Decision Date October 07, 1996
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 General Hospital devices follow this clearance model.

Regulatory Peers - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 106
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K962849.
PERIPHERALLY INSERTED CENTRAL CATHETER
K964929 · B.Braun Medical, Inc. · Jun 1997
SOFT TIP MULTI-LUMEN CENTRAL VENOUS CATHETER
K971085 · B.Braun Medical, Inc. · Jun 1997
PERIPHERALLY INSERTED MEDLINE CATHETER
K963257 · Arrow Intl., Inc. · Mar 1997
AUTO SUTURE CHEMOSITE TUNNELER
K961856 · United States Surgical, A Division of Tyco Healthc · Jul 1996
PER-Q-CATH & PER-Q-CATH DUAL MUMEN CATHETERS, TRAYS & ACCESSORY DEVICES
K954104 · C.R. Bard, Inc. · Nov 1995
ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETER
K930129 · Arrow Intl., Inc. · Mar 1994