Cleared Traditional

CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING (K926138) - FDA 510(k) Clearance

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

K926138 · Baxter Healthcare Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
197d
Days
Class 2
Risk

K926138 is an FDA 510(k) clearance for the CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING. Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on June 22, 1993 after a review of 197 days - an extended review 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: 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K926138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received December 07, 1992
Decision Date June 22, 1993
Days to Decision 197 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 125d · This submission: 197d
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 24
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K926138.
CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R
K061127 · Medtronic Vascular · May 2006
MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
K011395 · Medtronic Vascular · Jul 2001
MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M
K984435 · Medtronic Vascular · Jan 1999
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