Cleared Traditional

K991259 - TE ME NA EPIDURAL CATHETER

K991259 is an FDA 510(k) clearance for TE ME NA EPIDURAL CATHETER, manufactured by Te ME NA S.A.R.L.. The device is a Class 2 Anesthesiology device with product code BSO cleared through the Traditional 510(k) pathway after a 680-day FDA review.

K991259 · Te ME NA S.A.R.L. · Anesthesiology device
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Feb 2001
Decision
680d
Days
Class 2
Risk

K991259 is an FDA 510(k) clearance for the TE ME NA EPIDURAL CATHETER. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Te ME NA S.A.R.L. (Oldsmar, US). The FDA issued a Cleared decision on February 21, 2001 after a review of 680 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Te ME NA S.A.R.L. devices

FDA 510(k) Submission Details - K991259

510(k) Number K991259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1999
Decision Date February 21, 2001
Days to Decision 680 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
540d slower than avg
Panel avg: 140d · This submission: 680d
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 51
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K991259.
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K023233 · Ebi, L.P. · Dec 2002
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K022019 · B.Braun Medical, Inc. · Aug 2002
SPIROL EPIDURAL CATHETER
K000886 · Abbott Laboratories · Oct 2000
AXIOM MULTIPURPOSE WOUND DRAIN
K993592 · Axiom Medical, Inc. · May 2000
SPRING-WOUND EPIDURAL CATHETER
K991879 · Micor, Inc. · Oct 1999