Cleared Traditional

K000886 - SPIROL EPIDURAL CATHETER

K000886 is an FDA 510(k) clearance for SPIROL EPIDURAL CATHETER, manufactured by Abbott Laboratories. The device is a Class 2 Anesthesiology device with product code BSO cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K000886 · Abbott Laboratories · Anesthesiology device
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Oct 2000
Decision
199d
Days
Class 2
Risk

K000886 is an FDA 510(k) clearance for the SPIROL EPIDURAL CATHETER. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 5, 2000 after a review of 199 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K000886

510(k) Number K000886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2000
Decision Date October 05, 2000
Days to Decision 199 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
59d slower than avg
Panel avg: 140d · This submission: 199d
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 41
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K000886.
MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
K032390 · Ebi, L.P. · Aug 2003
EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
K023233 · Ebi, L.P. · Dec 2002
PERIFIX CATHETER CONNECTOR
K022019 · B.Braun Medical, Inc. · Aug 2002
AXIOM MULTIPURPOSE WOUND DRAIN
K993592 · Axiom Medical, Inc. · May 2000
INTERPLEURAL ANESTHESIA CATHETER
K971851 · Axiom Medical, Inc. · Jan 1998
CATHETER SECUREMENT DEVICE
K951092 · Baxter Healthcare Corp · Mar 1995