Cleared Traditional

BEECH VERSA LOK (K933749) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K933749 · Beech Medical Products, Inc. · General Hospital
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Dec 1993
Decision
148d
Days
Class 2
Risk

K933749 is an FDA 510(k) clearance for the BEECH VERSA LOK. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Beech Medical Products, Inc. (Newtown, US). The FDA issued a Cleared decision on December 29, 1993 after a review of 148 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Beech Medical Products, Inc. devices

Submission Details

510(k) Number K933749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1993
Decision Date December 29, 1993
Days to Decision 148 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 129d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 General Hospital devices follow this clearance model.

Regulatory Peers - FPA Set, Administration, Intravascular

All 234
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K933749.
ENERGIZED DRUG CONTAINER SYSTEM
K934119 · Abbott Laboratories · Jun 1994
CONTROL-A-FLO(TM) REGULATOR
K940867 · Baxter Healthcare Corp · May 1994
LIFECARE PLUMSET VENTED SECONDARY I.V. SET
K933326 · Abbott Laboratories · Mar 1994
ENERGIZED CONTAINER SYSTEM
K925418 · Abbott Laboratories · Nov 1993
SUB-Q-SET(R) SUBCUTANEOUS INFUSION SET
K925362 · Baxter Healthcare Corp · Aug 1993
BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET
K925058 · C.R. Bard, Inc. · Aug 1993