Cleared Traditional

K913235 - DAVOL IMPLANT PORTS W/ATTACH HI PERF GR...

K913235 is the FDA 510(k) clearance for DAVOL IMPLANT PORTS W/ATTACH HI PERF GR... by Davol, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K913235 · Davol, Inc. · General Hospital
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Oct 1991
Decision
101d
Days
Class 2
Risk

K913235 is an FDA 510(k) clearance for the DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Davol, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 31, 1991 after a review of 101 days - within the typical 510(k) review window.

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: 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 Davol, Inc. devices

Submission Details

510(k) Number K913235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1991
Decision Date October 31, 1991
Days to Decision 101 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
28d faster than avg
Panel avg: 129d · This submission: 101d
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 285
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K913235.
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