Cleared Traditional

K883345 - SARNS INFANT VENOUS RESERVOIR MODEL #16387

K883345 is the FDA 510(k) clearance for SARNS INFANT VENOUS RESERVOIR MODEL #16387 by 3M Health Care, Sarns. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K883345 · 3M Health Care, Sarns · Cardiovascular device
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Sep 1988
Decision
50d
Days
Class 2
Risk

K883345 is an FDA 510(k) clearance for the SARNS INFANT VENOUS RESERVOIR MODEL #16387. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on September 28, 1988 after a review of 50 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all 3M Health Care, Sarns devices

Submission Details

510(k) Number K883345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1988
Decision Date September 28, 1988
Days to Decision 50 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 125d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 126
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K883345.
BLOOD RESERVOIR, CARDIOPULMONARY BYPASS
K882414 · Gish Biomedical, Inc. · Dec 1988
CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES
K883923 · Gish Biomedical, Inc. · Nov 1988
SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR
K882380 · Scimed Life Systems, Inc. · Oct 1988
SCIMED R30 SILICONE ASSIST RESERVOIR
K882720 · Scimed Life Systems, Inc. · Sep 1988
MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER
K873423 · Johnson & Johnson Professionals, Inc. · Nov 1987
EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER
K872719 · Shiley, Inc. · Sep 1987