Cleared Traditional

K926138 - CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

K926138 is an FDA 510(k) clearance for CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING, manufactured by Baxter Healthcare Corp. The device is a Class 2 Cardiovascular device with product code KRH cleared through the Traditional 510(k) pathway after a 197-day FDA review.

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

FDA 510(k) Submission Details - K926138

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.

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 61
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K926138.
ANNULOFLO SYSTEM
K970375 · Carbomedics, Inc. · Jul 1997
SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M
K961246 · St. Jude Medical, Inc. · Feb 1997
POSTERIOR ANNULOPLASTY BAND (MODEL 607)
K960356 · The Heart Valve Div. Medtronic Cardiovascular Surg · Aug 1996
COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600
K923367 · Baxter Healthcare Corp · Jan 1993
PTI ANNULOPLASTY RING(STERILE)
K905175 · Pioneering Technologies, Inc. · Feb 1992
CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS
K914972 · Baxter Healthcare Corp · Jan 1992