Cleared Traditional

K980536 - EPIDURAL NEEDLE

K980536 is an FDA 510(k) clearance for EPIDURAL NEEDLE, 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 170-day FDA review.

K980536 · Manan Medical Products, Inc. · Anesthesiology device
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Jul 1998
Decision
170d
Days
Class 2
Risk

K980536 is an FDA 510(k) clearance for the EPIDURAL NEEDLE. 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 July 31, 1998 after a review of 170 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 Manan Medical Products, Inc. devices

FDA 510(k) Submission Details - K980536

510(k) Number K980536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1998
Decision Date July 31, 1998
Days to Decision 170 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
30d slower than avg
Panel avg: 140d · This submission: 170d
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 K980536.
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
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
SPINAL NEEDLES
K961151 · Hakko Shoji Co., Ltd. · Mar 1997