Cleared Traditional

K951736 - LOCK-UP

K951736 is an FDA 510(k) clearance for LOCK-UP, manufactured by Medline. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K951736 · Medline · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
83d
Days
Class 2
Risk

K951736 is an FDA 510(k) clearance for the LOCK-UP. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Medline (Mundelein, US). The FDA issued a Cleared decision on July 5, 1995 after a review of 83 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.

FDA 510(k) Submission Details - K951736

510(k) Number K951736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1995
Decision Date July 05, 1995
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
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 608
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K951736.
CAPCARD
K942930 · Capcard, Inc. · Jul 1995
SHARPS AWAY
K943765 · Biomedical Waste Systems, Inc. · Jul 1995
DEVONS POINT LOK NEEDLE PROTECTION DEVICE
K946289 · Devon Industries, Inc. · Jul 1995
LABORATORY SHARPS BARREL
K950899 · Biosystems · Jun 1995
ISOLYSER SHARPS MANAGEMENT SYSTEM SMS
K943626 · Thantex Specialties, Inc. · Jun 1995
CARDICO SHARPS CONTAINERS (1.5, 5, 9, 13, 21QTS.)
K946041 · Cardico, Inc. · Jun 1995
K951736 · LOCK-UP
Download PDF FDA Summary Medline