Cleared Traditional

K010692 - THE WAND PLUS COMPUTER CONTROLLED ANEST...

K010692 is an FDA 510(k) clearance for THE WAND PLUS COMPUTER CONTROLLED ANEST..., manufactured by Spintech, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K010692 · Spintech, Inc. · General Hospital
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Jun 2001
Decision
113d
Days
Class 2
Risk

K010692 is an FDA 510(k) clearance for the THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Spintech, Inc. (Washington, US). The FDA issued a Cleared decision on June 29, 2001 after a review of 113 days - within the typical 510(k) review window.

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.

View all Spintech, Inc. devices

FDA 510(k) Submission Details - K010692

510(k) Number K010692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2001
Decision Date June 29, 2001
Days to Decision 113 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
16d faster than avg
Panel avg: 129d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
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 - FMF Syringe, Piston

All 330
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K010692.
MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP
K020147 · Medtronic Perfusion Systems · Apr 2002
MICROMEDICS FIBRIJET AEROSOL APPLICATOR
K012868 · Micromedics, Inc. · Oct 2001
ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE
K011087 · Orthovita, Inc. · Sep 2001
APPLICATOR TIP/DUAL SPRAYER KIT
K010708 · Interpore Cross Intl. · Apr 2001
SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE
K003571 · Terumo Medical Corp. · Feb 2001
STERILE PISTON SYRINGE
K002717 · Abbott Laboratories · Jan 2001