Cleared Traditional

K962849 - CATHETER INSERTION TRAY

K962849 is an FDA 510(k) clearance for CATHETER INSERTION TRAY, manufactured by Medcare Medical Group, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K962849 · Medcare Medical Group, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K962849

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
Combination Product No
PCCP Authorized No
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.

LJS Device Classification - Class 2, Special Controls

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 289
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K962849.
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K963097 · Bmw Medical, Inc. · Oct 1996
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K960055 · Pudenz-Schulte Medical Research Corp. · Sep 1996
CLAMPLESS VALVED CATHETER
K962300 · Bmw Medical, Inc. · Sep 1996
MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652
K961336 · Medtronic PS Medical · Jul 1996
K962849 · CATHETER INSERTION TRAY
Download PDF FDA Summary Medcare Medical Group…