Cleared Traditional

K820453 - THE INT-STOPPER

K820453 is the FDA 510(k) clearance for THE INT-STOPPER by Burron Medical Products, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K820453 · Burron Medical Products, Inc. · General Hospital
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Mar 1982
Decision
18d
Days
Class 2
Risk

K820453 is an FDA 510(k) clearance for the THE INT-STOPPER. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Burron Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 8, 1982 after a review of 18 days - a notably fast clearance 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: 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 Burron Medical Products, Inc. devices

Submission Details

510(k) Number K820453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1982
Decision Date March 08, 1982
Days to Decision 18 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 129d · This submission: 18d
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 307
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K820453.
VENTED NITROGLYCERIN I.V. SET
K821515 · Abbott Laboratories · Jun 1982
MONOJECT SAF-T-LOCK
K820747 · Sherwood Medical Co. · Apr 1982
CLIRANS PRIMING SET
K820788 · Terumo Medical Corp. · Apr 1982
INTRAVASCULAR ADMINISTRATION SET
K820278 · Y · Feb 1982
AUTO-SYRINGE SUB-CUTEANEOUS SET
K813194 · Baxter Healthcare Corp · Dec 1981
QI 1150-1T INFUSION T
K812688 · Quinton, Inc. · Oct 1981