Cleared Traditional

K930154 - EL2-SERIES BLOOD COLLECTION REERVOIR

K930154 is the FDA 510(k) clearance for EL2-SERIES BLOOD COLLECTION REERVOIR by Electromedics, Inc.. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K930154 · Electromedics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
169d
Days
Class 2
Risk

K930154 is an FDA 510(k) clearance for the EL2-SERIES BLOOD COLLECTION REERVOIR. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Electromedics, Inc. (Englewood, US). The FDA issued a Cleared decision on July 1, 1993 after a review of 169 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 Electromedics, Inc. devices

Submission Details

510(k) Number K930154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1993
Decision Date July 01, 1993
Days to Decision 169 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 125d · This submission: 169d
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 78
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K930154.
SOFT VENOUS RESERVOIR
K955046 · Gish Biomedical, Inc. · Jan 1996
VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT
K933713 · Baxter Healthcare Corp · Mar 1994
ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)
K936286 · Gish Biomedical, Inc. · Feb 1994
BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET
K930299 · C.R. Bard, Inc. · Jun 1993
VENOUS RESERVOIR W/CARDIOTOMY FILTER
K915573 · Baxter Healthcare Corp · Dec 1992
MVR COLLAPSIBLE VENOUS RESERVOIR BAG
K920774 · Medtronic Vascular · Oct 1992