Cleared Traditional

K955554 - HEMO-VALVE

K955554 is the FDA 510(k) clearance for HEMO-VALVE by North American Instrument Corp.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

Device Classification

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 83
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K955554.
ADAPTERS WITH X-COATING
K003604 · Terumo Cardiovascular Systems Corp. · Feb 2001
MBA
K993057 · Merit Medical Systems, Inc. · Oct 1999
COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331
K991102 · Guidant Corp. · Jun 1999
QUEST VEIN GRAFT PERFUSION SET
K952531 · Quest Medical, Inc. · Aug 1995
BRAUN MANIFOLD
K942391 · B.Braun Medical, Inc. · Jun 1995
SCIMED GATEWAY PLUS
K951089 · Scimed Life Systems, Inc. · May 1995