Cleared Traditional

K023940 - SHELHIGH BIORING

K023940 is an FDA 510(k) clearance for SHELHIGH BIORING, manufactured by Shelhigh, Inc.. The device is a Class 2 Cardiovascular device with product code KRH cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K023940 · Shelhigh, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
190d
Days
Class 2
Risk

K023940 is an FDA 510(k) clearance for the SHELHIGH BIORING. Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by Shelhigh, Inc. (Union, US). The FDA issued a Cleared decision on June 4, 2003 after a review of 190 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 Shelhigh, Inc. devices

FDA 510(k) Submission Details - K023940

510(k) Number K023940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2002
Decision Date June 04, 2003
Days to Decision 190 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 125d · This submission: 190d
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 49
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K023940.
CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R
K061127 · Medtronic Vascular · May 2006
SJM RIGID SADDLE RING MODEL RSAR-(SIZE)
K042734 · St. Jude Medical, Inc. · Dec 2004
GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200
K032250 · Edwards Lifesciences, LLC · Aug 2003
SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)
K022363 · St. Jude Medical, Inc. · Sep 2002
EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900
K020864 · Edwards Lifesciences, LLC · Apr 2002
SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)
K014161 · St. Jude Medical, Inc. · Jan 2002