Cleared Traditional

K983620 - MANAN SPINAL NEEDLES

K983620 is an FDA 510(k) clearance for MANAN 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 85-day FDA review.

K983620 · Manan Medical Products, Inc. · Anesthesiology device
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Jan 1999
Decision
85d
Days
Class 2
Risk

K983620 is an FDA 510(k) clearance for the MANAN SPINAL NEEDLES. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Manan Medical Products, Inc. (Northbrook, US). The FDA issued a Cleared decision on January 8, 1999 after a review of 85 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 - K983620

510(k) Number K983620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1998
Decision Date January 08, 1999
Days to Decision 85 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
55d faster than avg
Panel avg: 140d · This submission: 85d
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 K983620.
CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK
K993619 · Sims Portex, Inc. · Apr 2000
UNIPOLAR NEEDLES
K000722 · Pajunk GmbH · Mar 2000
BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES
K000495 · Ballard Medical Products · Mar 2000
EPIDURAL NEEDLE
K980536 · Manan Medical Products, Inc. · Jul 1998
ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER
K972595 · Avid N.I.T., Inc. · May 1998
DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)
K951928 · Csen , Ltd. · May 1997