Cleared Traditional

K810921 - MALE LUER LOCK PLUGS

K810921 is an FDA 510(k) clearance for MALE LUER LOCK PLUGS, manufactured by Procedure Products, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K810921 · Procedure Products, Inc. · General Hospital
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May 1981
Decision
45d
Days
Class 2
Risk

K810921 is an FDA 510(k) clearance for the MALE LUER LOCK PLUGS. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Procedure Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 21, 1981 after a review of 45 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 Procedure Products, Inc. devices

FDA 510(k) Submission Details - K810921

510(k) Number K810921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1981
Decision Date May 21, 1981
Days to Decision 45 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
84d faster than avg
Panel avg: 129d · This submission: 45d
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 731
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K810921.
MODELS: 52-01-0, 52-01-1
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