Cleared Traditional

K895795 - HPD TUBING CONNECTORS

K895795 is an FDA 510(k) clearance for HPD TUBING CONNECTORS, manufactured by Hpd Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K895795 · Hpd Medical, Inc. · Cardiovascular device
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Jan 1990
Decision
121d
Days
Class 2
Risk

K895795 is an FDA 510(k) clearance for the HPD TUBING CONNECTORS. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Hpd Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on January 26, 1990 after a review of 121 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 Hpd Medical, Inc. devices

FDA 510(k) Submission Details - K895795

510(k) Number K895795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1989
Decision Date January 26, 1990
Days to Decision 121 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 125d · This submission: 121d
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 109
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K895795.
RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING
K897137 · Research Medical, Inc. · Mar 1990
ADVANCE STOPCOCKS ADVANCE MANIFOLDS
K897196 · Advance Medical Designs, Inc. · Mar 1990
ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI.
K897197 · Advance Medical Designs, Inc. · Mar 1990
RMI CARDIOPLEGIA DELIVERY SETS
K892368 · Research Medical, Inc. · Dec 1989
RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET
K892377 · Research Medical, Inc. · Dec 1989
SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM
K893683 · 3M Company · Aug 1989