Cleared Traditional

K912915 - SARNS NON-FILTERED VENOUS RESERVOIR

K912915 is an FDA 510(k) clearance for SARNS NON-FILTERED VENOUS RESERVOIR, manufactured by 3M Health Care, Ltd.. The device is a Class 2 Cardiovascular device with product code DTP cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K912915 · 3M Health Care, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1991
Decision
84d
Days
Class 2
Risk

K912915 is an FDA 510(k) clearance for the SARNS NON-FILTERED VENOUS RESERVOIR. Classified as Defoamer, Cardiopulmonary Bypass (product code DTP), Class II - Special Controls.

Submitted by 3M Health Care, Ltd. (Ann Arbor, US). The FDA issued a Cleared decision on September 25, 1991 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4230 - 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, Ltd. devices

FDA 510(k) Submission Details - K912915

510(k) Number K912915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1991
Decision Date September 25, 1991
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTP Device Classification - Class 2, Special Controls

Product Code DTP Defoamer, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4230
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 - DTP Defoamer, Cardiopulmonary Bypass

All 29
Devices cleared under the same product code (DTP) and FDA review panel - the closest regulatory comparables to K912915.
BARD QUANTUM CVR
K962726 · C.R. Bard, Inc. · Oct 1996
SARNS FILTERED VENOUS RESERVIOR MODIFICATION
K941654 · 3M Health Care, Sarns · Jul 1994
MAXIMA FILTERED HARDSHELL RESERVIOR
K933496 · Medtronic Vascular · Oct 1993
MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT
K911789 · Medtronic Vascular · Aug 1991
MODEL 5866-46 SLEEVE KIT
K910568 · Medtronic Vascular · Apr 1991
COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER
K902437 · Cobe Laboratories, Inc. · Dec 1990