Cleared Traditional

K932400 - ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE...

K932400 is an FDA 510(k) clearance for ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE..., manufactured by B. Braun of America, Inc.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K932400 · B. Braun of America, Inc. · Anesthesiology device
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Dec 1993
Decision
209d
Days
Class 2
Risk

K932400 is an FDA 510(k) clearance for the ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by B. Braun of America, Inc. (Bethlehem, US). The FDA issued a Cleared decision on December 13, 1993 after a review of 209 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 B. Braun of America, Inc. devices

FDA 510(k) Submission Details - K932400

510(k) Number K932400 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received May 18, 1993
Decision Date December 13, 1993
Days to Decision 209 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
69d slower than avg
Panel avg: 140d · This submission: 209d
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 69
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K932400.
MONOJECT TUOHY POINT EPIDURAL NEEDLE (22G X 3 1/2)
K951411 · Sherwood Medical Co. · May 1995
MONOJECT DIAMOND POINT SPINAL NEEDLE (28G X 3 1/2)
K951265 · Sherwood Medical Co. · Apr 1995
GERTIE MARX NEEDLE
K943649 · Manan Medical Products, Inc. · Mar 1995
PHARMASEAL CLEAR HUB SPINAL NEEDLE
K920305 · Baxter Healthcare Corp · Jan 1993
CURITY CALIBRATED TUOHY TYPE EPIDURAL NEEDLE
K921288 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jan 1993
CURITY(R) CALIB TUOHY TYPE EPIDUR NEEDLE FIX WING
K910791 · Kendall Healthcare Products Co. Div.Of Tyco Health · May 1991