Cleared Traditional

K930539 - MEDCOMP CONTINUOUS ANESTHESIA TRAY

K930539 is an FDA 510(k) clearance for MEDCOMP CONTINUOUS ANESTHESIA TRAY, manufactured by Medical Components, Inc.. The device is a Class 2 Anesthesiology device with product code BSO cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K930539 · Medical Components, Inc. · Anesthesiology device
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Aug 1993
Decision
206d
Days
Class 2
Risk

K930539 is an FDA 510(k) clearance for the MEDCOMP(R) CONTINUOUS ANESTHESIA TRAY. Classified as Catheter, Conduction, Anesthetic (product code BSO), Class II - Special Controls.

Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on August 27, 1993 after a review of 206 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 Medical Components, Inc. devices

FDA 510(k) Submission Details - K930539

510(k) Number K930539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1993
Decision Date August 27, 1993
Days to Decision 206 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
66d slower than avg
Panel avg: 140d · This submission: 206d
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 K930539.
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
KENDALL CURITY 20 GAUGE CONTINUOUS EPIDUAL ANESTHE
K930219 · Kendall Healthcare Products Co. Div.Of Tyco Health · Apr 1993
KENDALL CURITY CONTINUOUS EPIDDUAL ANESTHESIA CATH
K922113 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1992
PHARMASEAL EPIDURAL CATHETER
K896712 · Baxter Healthcare Corp · Jun 1990