Cleared Traditional

K820454 - THE RED CAP

K820454 is the FDA 510(k) clearance for THE RED CAP by Burron Medical Products, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K820454 · Burron Medical Products, Inc. · General Hospital
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Mar 1982
Decision
18d
Days
Class 2
Risk

K820454 is an FDA 510(k) clearance for the THE RED CAP. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Burron Medical Products, Inc. (Walker, 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 880.5860 - 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 K820454 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 FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 254
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K820454.
U-100 INSULIN SYRINGE
K822083 · Terumo Medical Corp. · Aug 1982
MONOJET 520 20CC SYRINGES W/NEEDLES
K822029 · Sherwood Medical Co. · Jul 1982
MONOJECT 512 SYRINGES W/WO NEEDLES
K820716 · Sherwood Medical Co. · Apr 1982
MONOJECT M560 60CC SYRINGES
K813480 · Sherwood Medical Co. · Jan 1982
20CC GLASS CONTROL SYRINGE
K813175 · Abco Dealers, Inc. · Nov 1981
MONOJECT PREFILLED SYRINGES
K812934 · Sherwood Medical Co. · Nov 1981