Cleared Traditional

K801879 - PUIG MASSANA-SHILEY ANNULOPLASTY RING

K801879 is an FDA 510(k) clearance for PUIG MASSANA-SHILEY ANNULOPLASTY RING, manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code KRH cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K801879 · Shiley, Inc. · Cardiovascular device
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Dec 1980
Decision
132d
Days
Class 2
Risk

K801879 is an FDA 510(k) clearance for the PUIG MASSANA-SHILEY ANNULOPLASTY RING. Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by Shiley, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 16, 1980 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3800 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Shiley, Inc. devices

FDA 510(k) Submission Details - K801879

510(k) Number K801879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1980
Decision Date December 16, 1980
Days to Decision 132 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 125d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRH Device Classification - Class 2, Special Controls

Product Code KRH Ring, Annuloplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3800
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - KRH Ring, Annuloplasty

All 42
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K801879.
ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI
K912554 · Baxter Healthcare Corp · Sep 1991
PROSTHETIC RINGS #4400 MITRAL & 4500
K831949 · American Edwards Laboratories · Jul 1983
PUIG MASSANA-SHILEY ANNULOPLASTY RING
K821261 · Shiley, Inc. · Jun 1982
AMP DIRECT VASCULAR MONITORING SYSTEM
K792646 · American Medical Products, Inc. · Feb 1980