Cleared Traditional

K032981 - SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09

K032981 is an FDA 510(k) clearance for SPPRO ESP, manufactured by Invamed Technologies, Inc.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K032981 · Invamed Technologies, Inc. · Anesthesiology device
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Apr 2004
Decision
211d
Days
Class 2
Risk

K032981 is an FDA 510(k) clearance for the SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Invamed Technologies, Inc. (Littleton, US). The FDA issued a Cleared decision on April 22, 2004 after a review of 211 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5150 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Invamed Technologies, Inc. devices

FDA 510(k) Submission Details - K032981

510(k) Number K032981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2003
Decision Date April 22, 2004
Days to Decision 211 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 140d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSP Device Classification - Class 2, Special Controls

Product Code BSP Needle, Conduction, Anesthetic (w/wo Introducer)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5150
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BSP Needle, Conduction, Anesthetic (w/wo Introducer)

All 96
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K032981.
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