Cleared Traditional

K992471 - SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17

Also marketed or referenced as:
21G MODEL# 4910-18

K992471 is an FDA 510(k) clearance for SIMS PORTEX EPIDURAL CATHETER, manufactured by Sims Portex, Inc.. The device is a Class 2 Anesthesiology device with product code BSO cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K992471 · Sims Portex, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
88d
Days
Class 2
Risk

K992471 is an FDA 510(k) clearance for the SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Sims Portex, Inc. (Keene, US). The FDA issued a Cleared decision on October 22, 1999 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sims Portex, Inc. devices

FDA 510(k) Submission Details - K992471

510(k) Number K992471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1999
Decision Date October 22, 1999
Days to Decision 88 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
52d faster than avg
Panel avg: 140d · This submission: 88d
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 47
Devices cleared under the same product code (BSO) and FDA review panel - the closest regulatory comparables to K992471.
PERIFIX CATHETER CONNECTOR
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
FETH-R-KATH
K981329 · Epimed International, Inc. · Aug 1998
INTERPLEURAL ANESTHESIA CATHETER
K971851 · Axiom Medical, Inc. · Jan 1998
CATHETER SECUREMENT DEVICE
K951092 · Baxter Healthcare Corp · Mar 1995