Cleared Traditional

PUIG MASSANA-SHILEY ANNULOPLASTY RING (K821261) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K821261 · Shiley, Inc. · Cardiovascular device
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Jun 1982
Decision
44d
Days
Class 2
Risk

K821261 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 June 16, 1982 after a review of 44 days - a notably fast clearance cycle.

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: 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 Shiley, Inc. devices

Submission Details

510(k) Number K821261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1982
Decision Date June 16, 1982
Days to Decision 44 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
81d faster than avg
Panel avg: 125d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 30
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K821261.
COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600
K923367 · Baxter Healthcare Corp · Jan 1993
CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS
K914972 · Baxter Healthcare Corp · Jan 1992
ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI
K912554 · Baxter Healthcare Corp · Sep 1991
PUIG MASSANA-SHILEY ANNULOPLASTY RING
K801879 · Shiley, Inc. · Dec 1980