Cleared Traditional

K955554 - HEMO-VALVE

K955554 is an FDA 510(k) clearance for HEMO-VALVE, manufactured by North American Instrument Corp.. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K955554 · North American Instrument Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 1996
Decision
90d
Days
Class 2
Risk

K955554 is an FDA 510(k) clearance for the HEMO-VALVE. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by North American Instrument Corp. (Glens Falls, US). The FDA issued a Cleared decision on March 4, 1996 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4290 - 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 North American Instrument Corp. devices

FDA 510(k) Submission Details - K955554

510(k) Number K955554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1995
Decision Date March 04, 1996
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTL Device Classification - Class 2, Special Controls

Product Code DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4290
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 - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

All 107
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K955554.
MANIFOLD
K972654 · Medical Specialties Intl., Inc. · Oct 1997
HIGH PRESSURE INJECTION LINES
K963749 · Maxxim Medical · Dec 1996
NMI VEIN GRAFT PERFUSION SET
K961181 · Naltiac Medical, Inc. · Jun 1996
MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON)
K954284 · Medi-Plast Intl., Inc. · Feb 1996
MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE
K953564 · Medtronic Cardiac Surgery, Medtronic, Inc. · Feb 1996
QUEST VEIN GRAFT PERFUSION SET
K952531 · Quest Medical, Inc. · Aug 1995