Cleared Traditional

K960963 - CORD WRAP WITH NEEDLE RESHEATHER

K960963 is an FDA 510(k) clearance for CORD WRAP WITH NEEDLE RESHEATHER, manufactured by Osborn Medical Corp.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K960963 · Osborn Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
56d
Days
Class 2
Risk

K960963 is an FDA 510(k) clearance for the CORD WRAP WITH NEEDLE RESHEATHER. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Osborn Medical Corp. (Utica, US). The FDA issued a Cleared decision on May 6, 1996 after a review of 56 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 Osborn Medical Corp. devices

FDA 510(k) Submission Details - K960963

510(k) Number K960963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1996
Decision Date May 06, 1996
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
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 405
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K960963.
BEC SHROUDED PLASTIC CANNULA
K961328 · Biological & Environmental Control Laboratories · May 1996
PERRY SPECIALTIES DESIGNS NEEDLE GUARD
K932889 · Perry Specialties Design, Inc. · May 1996
RECAP-1
K960641 · Medscience, Inc. · May 1996
NON-CORING NEEDLE
K960698 · Med Institute, Inc. · Apr 1996
DOYLE EXTRACTOR
K955748 · Safetech Intl., Inc. · Mar 1996
SHARPSPRO-TECTOR
K942073 · Superior Diapering Products , Ltd. · Feb 1996