Cleared Traditional

K905818 - VACUUM-ASSISTED BLOOD COLLECTION SYSTEM

K905818 is an FDA 510(k) clearance for VACUUM-ASSISTED BLOOD COLLECTION SYSTEM, manufactured by Jtl Medical Corp.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K905818 · Jtl Medical Corp. · Cardiovascular device
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Jun 1991
Decision
157d
Days
Class 2
Risk

K905818 is an FDA 510(k) clearance for the VACUUM-ASSISTED BLOOD COLLECTION SYSTEM. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Jtl Medical Corp. (Riverside, US). The FDA issued a Cleared decision on June 6, 1991 after a review of 157 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - 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 Jtl Medical Corp. devices

FDA 510(k) Submission Details - K905818

510(k) Number K905818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1990
Decision Date June 06, 1991
Days to Decision 157 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 125d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTN Device Classification - Class 2, Special Controls

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 149
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K905818.
VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)
K913692 · Bentley Laboratories, Inc. · Nov 1991
MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG
K911790 · Medtronic Vascular · Aug 1991
SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200
K911876 · Shiley, Inc. · Aug 1991
COBE ICU CONVERSION KIT
K902631 · Cobe Laboratories, Inc. · Dec 1990
INTERSEPT 1375 VENOUS RESERVOIR
K903632 · Medtronic Vascular · Dec 1990
SOFTSHELL VENOUS RESERVOIR
K904040 · C.R. Bard, Inc. · Dec 1990