Cleared Traditional

K970375 - ANNULOFLO SYSTEM

K970375 is an FDA 510(k) clearance for ANNULOFLO SYSTEM, manufactured by Carbomedics, Inc.. The device is a Class 2 Cardiovascular device with product code KRH cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K970375 · Carbomedics, Inc. · Cardiovascular device
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Jul 1997
Decision
172d
Days
Class 2
Risk

K970375 is an FDA 510(k) clearance for the ANNULOFLO SYSTEM. Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by Carbomedics, Inc. (Austin, US). The FDA issued a Cleared decision on July 25, 1997 after a review of 172 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 Carbomedics, Inc. devices

FDA 510(k) Submission Details - K970375

510(k) Number K970375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received February 03, 1997
Decision Date July 25, 1997
Days to Decision 172 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
47d slower than avg
Panel avg: 125d · This submission: 172d
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 44
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K970375.
MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
K011395 · Medtronic Vascular · Jul 2001
SJM TAILOR ANNULOPLASTY RING, MODEL TARN
K000119 · St. Jude Medical, Inc. · Feb 2000
MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M
K984435 · Medtronic Vascular · Jan 1999
SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M
K961246 · St. Jude Medical, Inc. · Feb 1997
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
K926138 · Baxter Healthcare Corp · Jun 1993
COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600
K923367 · Baxter Healthcare Corp · Jan 1993