Cleared Traditional

K012726 - PROSAFE SAFETY SYRINGE

K012726 is an FDA 510(k) clearance for PROSAFE SAFETY SYRINGE, manufactured by Hou-Se Medical, Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K012726 · Hou-Se Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
64d
Days
Class 2
Risk

K012726 is an FDA 510(k) clearance for the PROSAFE SAFETY SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Hou-Se Medical, Inc. (Irving, US). The FDA issued a Cleared decision on October 18, 2001 after a review of 64 days - a notably fast clearance 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: 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 - K012726

510(k) Number K012726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2001
Decision Date October 18, 2001
Days to Decision 64 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
65d faster than avg
Panel avg: 129d · This submission: 64d
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 K012726.
ULTRASAFE DENTAL INJECTION SYSTEM
K013801 · Safety Syringes, Inc. · Dec 2001
3CC NMT SAFETY SYRINGE
K010819 · New Medical Technology , Ltd. · Nov 2001
SECUREGUARD RETRACTABLE SAFETY SYRINGE
K012121 · Safegard Medical Products, Inc. · Oct 2001
AUTO-LOCK
K010477 · Auto-Lock · Oct 2001
SOLO-SAFE SAFETY SYRINGE, SIZE-3CC
K003555 · Spectrum Biotech, Inc. · Aug 2001
BD SPRING BASED SYRINGE
K011103 · Bd · Jun 2001
K012726 · PROSAFE SAFETY SYRINGE
Download PDF FDA Summary Hou-Se Medical, Inc.