Cleared Traditional

K010477 - AUTO-LOCK

K010477 is an FDA 510(k) clearance for AUTO-LOCK, manufactured by Auto-Lock. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K010477 · Auto-Lock · General Hospital
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Oct 2001
Decision
231d
Days
Class 2
Risk

K010477 is an FDA 510(k) clearance for the AUTO-LOCK. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Auto-Lock (San Rafael, US). The FDA issued a Cleared decision on October 9, 2001 after a review of 231 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K010477

510(k) Number K010477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2001
Decision Date October 09, 2001
Days to Decision 231 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 129d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEG Device Classification - Class 2, Special Controls

Product Code MEG Syringe, Antistick
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - MEG Syringe, Antistick

All 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K010477.
3CC NMT SAFETY SYRINGE
K010819 · New Medical Technology , Ltd. · Nov 2001
SECUREGUARD RETRACTABLE SAFETY SYRINGE
K012121 · Safegard Medical Products, Inc. · Oct 2001
PROSAFE SAFETY SYRINGE
K012726 · Hou-Se Medical, Inc. · Oct 2001
SOLO-SAFE SAFETY SYRINGE, SIZE-3CC
K003555 · Spectrum Biotech, Inc. · Aug 2001
BD SPRING BASED SYRINGE
K011103 · Bd · Jun 2001
ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY)
K011369 · Safety Syringes, Inc. · May 2001
K010477 · AUTO-LOCK
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