Cleared Traditional

K931658 - IN-LINE BURETTE SET

K931658 is an FDA 510(k) clearance for IN-LINE BURETTE SET, manufactured by Douglas Medical Products Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K931658 · Douglas Medical Products Corp. · General Hospital
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Dec 1993
Decision
260d
Days
Class 2
Risk

K931658 is an FDA 510(k) clearance for the IN-LINE BURETTE SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Douglas Medical Products Corp. (Mundelein, US). The FDA issued a Cleared decision on December 21, 1993 after a review of 260 days - an extended review cycle.

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 Douglas Medical Products Corp. devices

FDA 510(k) Submission Details - K931658

510(k) Number K931658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1993
Decision Date December 21, 1993
Days to Decision 260 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 129d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

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 571
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K931658.
EZ ADMINISTRATION SET
K931550 · Y · Jan 1994
3 LEAD CONNECTOR
K931659 · Douglas Medical Products Corp. · Jan 1994
SUBCUTANEOUS INFUSION SET
K932637 · Douglas Medical Products Corp. · Jan 1994
HUBER NEEDLE INFUSION SET
K932638 · Douglas Medical Products Corp. · Dec 1993
INJECTION SITE
K932446 · 3M Health Care, Ltd. · Nov 1993
ENERGIZED CONTAINER SYSTEM
K925418 · Abbott Laboratories · Nov 1993