Cleared Traditional

K812657 - INJECTION CAP, LUER LOCK

K812657 is an FDA 510(k) clearance for INJECTION CAP, 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 35-day FDA review.

K812657 · Procedure Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1981
Decision
35d
Days
Class 2
Risk

K812657 is an FDA 510(k) clearance for the INJECTION CAP, LUER LOCK. 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 October 23, 1981 after a review of 35 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 - K812657

510(k) Number K812657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1981
Decision Date October 23, 1981
Days to Decision 35 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
94d faster than avg
Panel avg: 129d · This submission: 35d
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 K812657.
IN-STOPPER (INJECTION CAP
K813259 · Burron Medical Products, Inc. · Dec 1981
AUTO-SYRINGE SUB-CUTEANEOUS SET
K813194 · Baxter Healthcare Corp · Dec 1981
VENOFIX SCALP VEIN SET
K813083 · Burron Medical Products, Inc. · Nov 1981
QI 1150-1T INFUSION T
K812688 · Quinton, Inc. · Oct 1981
30-30-2 700 SYRINGE EXTENSION SET
K811885 · Y · Aug 1981
INTRAVENOUS ADMINISTRATION SET
K812231 · Cordis Corp. · Aug 1981