Cleared Traditional

K011209 - MANAN SPRITACRE SPINAL NEEDLES

K011209 is an FDA 510(k) clearance for MANAN SPRITACRE SPINAL NEEDLES, manufactured by Manan Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K011209 · Manan Medical Products, Inc. · Anesthesiology device
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Jun 2001
Decision
68d
Days
Class 2
Risk

K011209 is an FDA 510(k) clearance for the MANAN SPRITACRE SPINAL NEEDLES. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Manan Medical Products, Inc. (Wheeling, US). The FDA issued a Cleared decision on June 26, 2001 after a review of 68 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Manan Medical Products, Inc. devices

FDA 510(k) Submission Details - K011209

510(k) Number K011209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2001
Decision Date June 26, 2001
Days to Decision 68 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 140d · This submission: 68d
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 118
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K011209.
LUTZ NEEDLE
K013892 · Ballard Medical Products · Jul 2002
PERIFIX SAFETY EPIDURAL NEEDLES
K013610 · B.Braun Medical, Inc. · Jan 2002
BALLPEN SPINAL NEEDLE W/WO INTRODUCER
K011122 · Rusch Intl. · Nov 2001
PHOENIX EPIDURAL & SPINAL NEEDLES
K990519 · Myco Medical Supplies, Inc. · Jun 2000
CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK
K993619 · Sims Portex, Inc. · Apr 2000
UNIPOLAR NEEDLES
K000722 · Pajunk GmbH · Mar 2000