Cleared Traditional

K954525 - SENSI-TOUCH EPIDURAL ANESTHESIA FILTER

K954525 is an FDA 510(k) clearance for SENSI-TOUCH EPIDURAL ANESTHESIA FILTER, manufactured by Sherwood Medical Co.. The device is a Class 2 Anesthesiology device with product code BXN cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K954525 · Sherwood Medical Co. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
112d
Days
Class 2
Risk

K954525 is an FDA 510(k) clearance for the SENSI-TOUCH EPIDURAL ANESTHESIA FILTER. Classified as Stimulator, Nerve, Battery-powered (product code BXN), Class II - Special Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on January 19, 1996 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2775 - 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.

FDA 510(k) Submission Details - K954525

510(k) Number K954525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1995
Decision Date January 19, 1996
Days to Decision 112 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 140d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BXN Device Classification - Class 2, Special Controls

Product Code BXN Stimulator, Nerve, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2775
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 - BXN Stimulator, Nerve, Battery-powered

All 62
Devices cleared under the same product code (BXN) and FDA review panel - the closest regulatory comparables to K954525.
MULTISTIM
K011308 · Pajunk GmbH · Nov 2001
TE ME NA POLYSTIM NERVE STIMILATOR
K990323 · Te ME NA S.A.R.L. · Sep 2001
STIMUPLEX HNS-11
K003983 · Stockert GmbH · Jun 2001
VITALMAX 840 SERIES
K914164 · Pace Tech Medical Monitors, Inc. · Apr 1993
MS-III MINISTIM
K913184 · Life-Tech Intl., Inc. · Oct 1991
NEUROMUSCULAR TRANSMISSION MONITOR
K905092 · Utah Medical Products, Inc. · Jun 1991
K954525 · SENSI-TOUCH EPIDURAL ANESTHESIA FILTER
Download PDF FDA Summary Sherwood Medical Co.