Cleared Traditional

K936261 - CATHETER INSERTION TRAY

K936261 is an FDA 510(k) clearance for CATHETER INSERTION TRAY, manufactured by Medcare Custom Packaging, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K936261 · Medcare Custom Packaging, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
80d
Days
Class 2
Risk

K936261 is an FDA 510(k) clearance for the CATHETER INSERTION TRAY. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Medcare Custom Packaging, Inc. (E Swanzey, US). The FDA issued a Cleared decision on March 10, 1994 after a review of 80 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Custom Packaging, Inc. devices

FDA 510(k) Submission Details - K936261

510(k) Number K936261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received December 20, 1993
Decision Date March 10, 1994
Days to Decision 80 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
49d faster than avg
Panel avg: 129d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 264
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K936261.
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