Cleared Traditional

K991879 - SPRING-WOUND EPIDURAL CATHETER

K991879 is an FDA 510(k) clearance for SPRING-WOUND EPIDURAL CATHETER, manufactured by Micor, Inc.. The device is a Class 2 Anesthesiology device with product code BSO cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K991879 · Micor, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
148d
Days
Class 2
Risk

K991879 is an FDA 510(k) clearance for the SPRING-WOUND EPIDURAL CATHETER. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Micor, Inc. (Allison Park, US). The FDA issued a Cleared decision on October 28, 1999 after a review of 148 days - within the typical 510(k) review window.

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 Micor, Inc. devices

FDA 510(k) Submission Details - K991879

510(k) Number K991879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1999
Decision Date October 28, 1999
Days to Decision 148 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
8d slower than avg
Panel avg: 140d · This submission: 148d
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 K991879.
TE ME NA EPIDURAL CATHETER
K991259 · Te ME NA S.A.R.L. · Feb 2001
SPIROL EPIDURAL CATHETER
K000886 · Abbott Laboratories · Oct 2000
AXIOM MULTIPURPOSE WOUND DRAIN
K993592 · Axiom Medical, Inc. · May 2000
SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17
K992471 · Sims Portex, Inc. · Oct 1999
FETH-R-KATH
K981329 · Epimed International, Inc. · Aug 1998
INTERPLEURAL ANESTHESIA CATHETER
K971851 · Axiom Medical, Inc. · Jan 1998