Cleared Traditional

K993619 - CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK

K993619 is an FDA 510(k) clearance for CSECURE COMBINED SPINAL/EPIDURAL ANESTH..., manufactured by Sims Portex, Inc.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K993619 · Sims Portex, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Apr 2000
Decision
185d
Days
Class 2
Risk

K993619 is an FDA 510(k) clearance for the CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Sims Portex, Inc. (Keene, US). The FDA issued a Cleared decision on April 28, 2000 after a review of 185 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 Sims Portex, Inc. devices

FDA 510(k) Submission Details - K993619

510(k) Number K993619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1999
Decision Date April 28, 2000
Days to Decision 185 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
45d slower than avg
Panel avg: 140d · This submission: 185d
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 87
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K993619.
BALLPEN SPINAL NEEDLE W/WO INTRODUCER
K011122 · Rusch Intl. · Nov 2001
MANAN SPRITACRE SPINAL NEEDLES
K011209 · Manan Medical Products, Inc. · Jun 2001
PHOENIX EPIDURAL & SPINAL NEEDLES
K990519 · Myco Medical Supplies, Inc. · Jun 2000
UNIPOLAR NEEDLES
K000722 · Pajunk GmbH · Mar 2000
BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES
K000495 · Ballard Medical Products · Mar 2000
MANAN SPINAL NEEDLES
K983620 · Manan Medical Products, Inc. · Jan 1999