Cleared Traditional

K905175 - PTI ANNULOPLASTY RING(STERILE)

K905175 is the FDA 510(k) clearance for PTI ANNULOPLASTY RING(STERILE) by Pioneering Technologies, Inc.. It is a Class 2 Cardiovascular device (product code KRH) cleared through the Traditional 510(k) pathway after a 452-day FDA review.

K905175 · Pioneering Technologies, Inc. · Cardiovascular device
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Feb 1992
Decision
452d
Days
Class 2
Risk

K905175 is an FDA 510(k) clearance for the PTI ANNULOPLASTY RING(STERILE). Classified as Ring, Annuloplasty (product code KRH), Class II - Special Controls.

Submitted by Pioneering Technologies, Inc. (Wheat Ridge, US). The FDA issued a Cleared decision on February 14, 1992 after a review of 452 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Pioneering Technologies, Inc. devices

Submission Details

510(k) Number K905175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1990
Decision Date February 14, 1992
Days to Decision 452 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
327d slower than avg
Panel avg: 125d · This submission: 452d
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 36
Devices cleared under the same product code (KRH) and FDA review panel - the closest regulatory comparables to K905175.
MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M
K984435 · Medtronic Vascular · Jan 1999
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
K926138 · Baxter Healthcare Corp · Jun 1993
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
PROSTHETIC RINGS #4400 MITRAL & 4500
K831949 · American Edwards Laboratories · Jul 1983