Cleared Traditional

K990519 - PHOENIX EPIDURAL & SPINAL NEEDLES

K990519 is an FDA 510(k) clearance for PHOENIX EPIDURAL & SPINAL NEEDLES, manufactured by Myco Medical Supplies, Inc.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 470-day FDA review.

K990519 · Myco Medical Supplies, Inc. · Anesthesiology device
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Jun 2000
Decision
470d
Days
Class 2
Risk

K990519 is an FDA 510(k) clearance for the PHOENIX EPIDURAL & SPINAL NEEDLES. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Myco Medical Supplies, Inc. (Cary, US). The FDA issued a Cleared decision on June 2, 2000 after a review of 470 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Myco Medical Supplies, Inc. devices

FDA 510(k) Submission Details - K990519

510(k) Number K990519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1999
Decision Date June 02, 2000
Days to Decision 470 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
330d slower than avg
Panel avg: 140d · This submission: 470d
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 73
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K990519.
PERIFIX SAFETY EPIDURAL NEEDLES
K013610 · B.Braun Medical, Inc. · Jan 2002
BALLPEN SPINAL NEEDLE W/WO INTRODUCER
K011122 · Rusch Intl. · Nov 2001
MANAN SPRITACRE SPINAL NEEDLES
K011209 · Manan Medical Products, Inc. · Jun 2001
BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES
K000495 · Ballard Medical Products · Mar 2000
MANAN SPINAL NEEDLES
K983620 · Manan Medical Products, Inc. · Jan 1999
EPIDURAL NEEDLE
K980536 · Manan Medical Products, Inc. · Jul 1998