Cleared Traditional

K072702 - STRYKER ANTIMIC CATHETER

K072702 is an FDA 510(k) clearance for STRYKER ANTIMIC CATHETER, manufactured by Stryker Instruments, Instruments Div.. The device is a Class 2 Anesthesiology device with product code BSO cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K072702 · Stryker Instruments, Instruments Div. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
177d
Days
Class 2
Risk

K072702 is an FDA 510(k) clearance for the STRYKER ANTIMIC CATHETER. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Stryker Instruments, Instruments Div. (Kalamazoo, US). The FDA issued a Cleared decision on March 19, 2008 after a review of 177 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5120 - 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 Stryker Instruments, Instruments Div. devices

FDA 510(k) Submission Details - K072702

510(k) Number K072702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2007
Decision Date March 19, 2008
Days to Decision 177 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
37d slower than avg
Panel avg: 140d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSO Device Classification - Class 2, Special Controls

Product Code BSO Catheter, Conduction, Anesthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5120
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 - BSO Catheter, Conduction, Anesthetic

All 46
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K072702.
Medline Epidural Catheter
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PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA.
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PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT
K080675 · PAJUNK GmbH Medizintechnologie · Jun 2008
BUSSE EPIDURAL CATHETER
K070465 · Busse Hospital Disposables, Inc. · Jul 2007
ON-Q INTRODUCERS
K063234 · I-Flow Corp. · Nov 2006
PORTEX EPIDURAL CATHETER
K062005 · Smiths Medical Asd, Inc. · Oct 2006